MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for ENOPTHALMOS WEDGE - REGULAR 9541 manufactured by Stryker Orthobiologics-malvern.
[41119378]
The device has been received at the manufacturer for testing. An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[41119379]
It was reported by the customer that item# 9541 (enopthalmos wedge) was received with 2 hairs in it.
Patient Sequence No: 1, Text Type: D, B5
[61004259]
Because one hair was found in the packaging, the reported event could be confirmed. Based on a review of nc/capa history regarding the failure mode for the affected product 9541 and for all similar products nc # (b)(4) followed by capa (b)(4) were found. This nc has been opened for a previous complaint (b)(4) and corrections and a capa have been implemented to prevent reoccurrence. Because the nc and the resulted capa have already been initiated, all corrections are implemented and the currently complained device has been manufactured before the actions were implemented, no further actions are necessary at this time. Product surveillance will continue to monitor complaints of this type for adverse trends. Therefore the reported failure (hair in the packaging) can be attributed to a manufacturing related root cause.
Patient Sequence No: 1, Text Type: N, H10
[61004260]
It was reported by the customer that item# 9541 (enopthalmos wedge) was received with 2 hairs in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00048 |
| MDR Report Key | 5515019 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-02-22 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2016-03-21 |
| 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 | MR. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENOPTHALMOS WEDGE - REGULAR |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2016-03-21 |
| Returned To Mfg | 2016-02-29 |
| Catalog Number | 9541 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-21 |