MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-18 for SPLINT WRIST COCKUP UNIV L N/A 00176900300 manufactured by Zimmer Surgical, Inc..
[86456897]
This event has been recorded by zimmer biomet under (b)(4). The receiving / inspection record (rir) for the universal left cock-up wrist splint, part number 00176900300 and lot number 46165, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing. The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed. On 05 dec 2016, it was reported from (b)(6) care that a universal left cock-up wrist splint caused the patient to break out in dermatitis while wearing the device. On 02 feb 2017, the foam material composition was investigated by the supplier based on a representative sample of the device from the reported manufacturing lot. The actual returned complaint product was not forwarded to the supplier for testing. The attached supplier survey and third party lab testing reveal that the raw materials used on the inside of the splint which touches the skin did not contain any chemicals that would cause irritation to the skin such as latex, formaldehyde, or dehp. The material was also confirmed to be reach compliant. The results of the returned product investigation can, therefore, not confirm the reported event. The supplier was not able to identify any allergens in the raw materials of the related lot nor identify any other issues that would cause an irritation for the user. The root cause of the reported event cannot be specifically determined with the provided information. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
Patient Sequence No: 1, Text Type: N, H10
[86456898]
It was reported that patient got contact dermatitis from wearing a wrist brace. Patient went back to the physician who recommended a cream that cleared up the rash approximately 3-5 days later. Instead of wearing the brace, he in turn had to get a cast put on. No additional patient consequences have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
[119064034]
This follow-up report is being filed to relay corrected information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001526350-2017-00688 |
| MDR Report Key | 6872040 |
| Report Source | CONSUMER |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2016-07-26 |
| Date Added to Maude | 2017-09-18 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPLINT WRIST COCKUP UNIV L |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2017-09-18 |
| Returned To Mfg | 2017-01-09 |
| Model Number | N/A |
| Catalog Number | 00176900300 |
| Lot Number | 46165 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-18 |