MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for DEROYAL 3-700A-02 manufactured by Caremax Rehabilitation Equipment Co.,ltd.
[33802897]
This product is not made by (b)(4). It is purchased from another company: (b)(4) the complaint sample was received. File" (b)(4)" is a picture of the broken crutch. According to the user facility, the patient was walking/crutching in the hall way of his house and it just snapped. He said he was not injured from the fall. The user facility verified that the patient was an adult in their late 20's and earlier 30's, who has a normal build (not overweight). The complaint sample was sent to engineering for evaluation. The engineer who inspected the sample stated it looked like one side of the uprights broke from fatigue cracking around the rivet hole that could be seen in the original picture. The engineer called it a fatigue fracture rather than an ultimate overload fracture is the lack of material drawing and thinning in the primary break region. The break edges have very little deformation as the fracture was generated from smaller cyclical loads that slowly propagate the fracture through the tubing body rather than one large load stretching and pulling the tubing apart. The second upright has a more pronounced bend which would be expected from the sudden load doubling from the loss of support of the first upright. This side contains more evidence of material drawing as the tubing was bent apart. This assessment was made by visual inspection of the complaint sample. Two possible reasons for the break are a small material defect or crack (not visible to naked eye) that failed due to critical loading of walking with the crutch; a process problem. Again, this is only speculation on the engineer's part. The investigation team has no other evidence other than the broken crutch. This sort of failure has not been previously reported. At the time of this writing, this is an isolated event. Nor further investigation can be performed as this product is not made by (b)(4). No root cause has been found. A supplier corrective action request (scar) will be sent to the manufacturer informing them of the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[33802898]
Quality issue details date of occurrence: (b)(6) 2015. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Patient/end consumer. Was a medical procedure involved? No. Detailed description of quality issue: patient was using the crutches when the crutch snapped in half. How was the quality issue was identified? By actual use. How was the product being used? Used as directed. Was it the initial use of the product? No. Was the product modified from the original condition supplied by (b)(4)? No. Was the product connected to or used in conjunction with other devices or equipment? No. Outcome details: outcome(s) attributed to quality issue: other. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient fell as a result of crutch snapping in half. Additional information requested by email: patient was walking/crutching in the hall way of his house and it just snapped. He said he was not injured from the fall. User facility stated that it was an adult in their late 20's and earlier 30's who has a normal build (not overweight).
Patient Sequence No: 1, Text Type: D, B5
[34099938]
The supplier corrective action request (scar) was returned. The vendor stated that they have "been established for more than 10 years of production enterprises, is the first time we have such customer response product quality problems". Also that they "will take the problem seriously". Correction: update- per the supplier corrective action request form (scar), the vendor will report the issue to their raw material supplier. Root cause analysis: update- per the supplier corrective action request form (scar), the vendor could find nothing wrong with the bending machine, but noted that the issue could be related to a production issue with the raw aluminum pipes. Corrective action and/or systemic correction action taken: update - per the supplier corrective action request form (scar) the vendor "will report the issue to the raw material supplier". "if possible require them to change to a better production equipment so that the raw material could reach to the higher quality level. " preventive action: update- the vendor listed no preventive action identified on the returned supplier corrective action request form (scar) 12/14/15 no further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1060680-2015-00047 |
| MDR Report Key | 5286712 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-11-14 |
| Date Facility Aware | 2015-11-14 |
| Date Mfgr Received | 2015-11-14 |
| Date Added to Maude | 2015-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MARIAN VARGAS |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | CAREMAX REHABILITATION EQUIPMENT CO.,LTD |
| Manufacturer Street | PINGNAN INDUSTRIAL AREA SHUGANG RD, PINGZHOU, NANHAI |
| Manufacturer City | FOSHAN, GUANGDONG 528251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 528251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2015-12-10 |
| Model Number | 3-700A-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX REHABILITATION EQUIPMENT CO.,LTD |
| Manufacturer Address | PINGNAN INDUSTRIAL AREA SHUGANG RD, PINGZHOU, NANHAI FOSHAN, GUANGDONG 528251 CH 528251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-10 |