MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for ZIMFOAM FINGER SPLINT N/A 66001700200 manufactured by Zimmer Surgical, Inc..
[95771134]
This event has been recorded by zimmer biomet under cmp-(b)(4). The device history record (dhr) for the zimfoam finger splint, part number 66001700200 and lot number 15120200, 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 (b)(6) 2016, it was reported from zimmer (b)(4) that two zimfoam finger splints had a loose particulate/ foreign substance in the product larger than 0. 60 mm. On 01 jun 2016, a returned product investigation was performed on the zimfoam finger splints. The physical evaluation revealed that the returned finger splints had a loose particulate/ foreign substance in the product. The results of the returned product investigation have confirmed the reported event. However, because the zimfoam finger splint is not a sterile product, there is no fault found with the product. The scope of that packaging materials inspection work instructions states on page 1 that? This process applies to all heat seals applied during sterile barrier packaging. This process also applies to all packaging materials and products?. While the returned product investigation confirmed that the zimfoam finger splint had a loose particulate/ foreign substance in the product, the zimfoam finger splint is a non-sterile product so there is no fault found with the product. Therefore, based on the information provided, a specific root cause of the reported event cannot be determined. 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
[95771135]
It was reported that loose particulate was found in the packaging. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2017-00960 |
| MDR Report Key | 7104222 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-12-16 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2017-12-16 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2017-12-11 |
| 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. 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 | 0 |
| Brand Name | ZIMFOAM FINGER SPLINT |
| Generic Name | SPLINT, HAND, AND COMPONENTS |
| Product Code | ILH |
| Date Received | 2017-12-11 |
| Returned To Mfg | 2016-05-10 |
| Model Number | N/A |
| Catalog Number | 66001700200 |
| Lot Number | 15120200 |
| 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 | 2017-12-11 |