MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-13 for SIZE NO. 4 - 19MM X 26MM X 9MM 7241 manufactured by Stryker Orthobiologics-malvern.
[48291770]
The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[48291771]
It was reported by a company representative that during incoming inspection a foreign material in the shape of a hair was found in a medpor package. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[73351078]
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 (b)(4) and for all similar products an nc followed by a capa were found. This nc has been opened for a previous complaint 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. No similar complaint has been recorded that was manufactured since the implementation of the actions. 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
[73351079]
It was reported by a company representative that during incoming inspection a foreign material in the shape of a hair was found in a medpor package. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00125 |
| MDR Report Key | 5721112 |
| Date Received | 2016-06-13 |
| Date of Report | 2017-03-20 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2014-11-13 |
| Date Added to Maude | 2016-06-13 |
| 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. HANS GEIGER |
| 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 | SIZE NO. 4 - 19MM X 26MM X 9MM |
| Generic Name | IMPLANT |
| Product Code | LYA |
| Date Received | 2016-06-13 |
| Returned To Mfg | 2016-05-27 |
| Catalog Number | 7241 |
| Lot Number | 72330 |
| 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 | 2016-06-13 |