MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-03-20 for 5 HOLE PIN CLAMP HOFFMANN II 49202020 manufactured by Stryker Osteosynthesis-selzach.
[3314080]
The customer reports that claw does not connect to equipment.
Patient Sequence No: 1, Text Type: D, B5
[3653676]
The customer reports that claw does not connect to equipment.
Patient Sequence No: 1, Text Type: D, B5
[10634864]
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[10995265]
Evaluation summary: the reported incident could not be confirmed, since the device was not returned for evaluation. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. Indications for any material, manufacturing or design related problems were not determined in the investigation. Please note that more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. If any further information is provided, the investigation report will be updated. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008031020-2013-00062 |
| MDR Report Key | 3013618 |
| Report Source | 08 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-02-21 |
| Date of Event | 2013-01-27 |
| Date Mfgr Received | 2013-06-13 |
| Device Manufacturer Date | 2012-03-08 |
| Date Added to Maude | 2013-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. CECILE GAROT |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 HOLE PIN CLAMP HOFFMANN II |
| Generic Name | IMPLANT |
| Product Code | JEC |
| Date Received | 2013-03-20 |
| Catalog Number | 49202020 |
| Lot Number | R00002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-20 |