MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-08-05 for OFFSET DOUBLE CLAMP 00-1238-004-00 manufactured by Zimmer Biomet Surgical.
[6365868]
It was reported that when the patient grabbed the trapeze bar to transfer in bed, the offset double clamp bar broke. The patient was hit by the traction setup and the staff member was hit in the head by the broken airborne clamp, and the hence staff member incurred injury. Additional information received indicated that there was no injury sustained by the patient; however the employee injured in the incident was treated for a concussion by a neurologist. The employee was stated to be recovering and was initially off-work for the injury; however the employee returned to work regular duty as of (b)(6) 2015. No further information regarding the name/identification of the employee or details of the treatment provided to the employee by the neurologist were able to be provided.
Patient Sequence No: 1, Text Type: D, B5
[14229704]
The device was not returned to the manufacturer at the time of this report. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[28510545]
The customer's complaint that the offset double clamp bar broke. The photographs provided by the customer confirmed this reported incident. The cause for the clamp to break was a modification of the clamp casting by drilling a second through hole. This second hole weakened the clamp casting. It appears in the photograph that the additional hole was drilled to rotate the location of the clamp jaw. It is not known if the re-drilling was performed by zimmer (b)(4) or superb manufacturing as an unauthorized and/or undocumented rework to correct the clamp location. Additionally, it is not known if the customer drilled the extra hole to modify the clamp location for a specific use. The cause for the component failure was due to the additional through hole. The root cause for the second hole is unknown. However, the current supplier for this product has amended their manufacturing instructions to add a quality caution: "quality concern: if the hole is drilled in the wrong location, do not re-drill the hole. This would cause the bar to be weakened and no longer be incompliance. The bar has to be scrapped out. This applies to all bars with holes drilled through them. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2015-00137 |
| MDR Report Key | 4974431 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-08-05 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-07-09 |
| Date Added to Maude | 2015-08-06 |
| 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 | MS. KATHLEEN SMITH |
| Manufacturer Street | 200 W. OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Manufacturer G1 | ZIMMER BIOMET SURGICAL |
| Manufacturer Street | 200 WEST OHIO AVE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OFFSET DOUBLE CLAMP |
| Generic Name | OFFSET DOUBLE CLAMP |
| Product Code | ILZ |
| Date Received | 2015-08-05 |
| Catalog Number | 00-1238-004-00 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-05 |