MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-14 for PIN,PASSING,DRILL TIP 2.4X381MM,STRL 7208678 manufactured by Smith & Nephew, Inc..
[54631108]
(b)(6). Visual inspection confirmed the reported complaint. The passing pin was broken 3cm from the distal tip. An exact root cause for the breakage could not be determined with confidence, however, further investigation found torsional force at the area of the break. A review of the device history records was performed which confirmed no inconsistencies. There were no internal processing issues, which could have contributed to the nature of the complaint. A complaint history review has not identified additional complaints for this lot number on file. There are no indications that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
[54631109]
It was reported that the passing pin broke in two while drilling the femoral tunnel. Both pieces were removed from the patient and the procedure was successfully completed. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2016-00609 |
| MDR Report Key | 5948394 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-14 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-03-24 |
| Date Mfgr Received | 2014-03-24 |
| Device Manufacturer Date | 2014-02-07 |
| Date Added to Maude | 2016-09-14 |
| 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 | JIM GONZALES |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIN,PASSING,DRILL TIP 2.4X381MM,STRL |
| Generic Name | GUIDE, DRILL, LIGAMENT |
| Product Code | LXI |
| Date Received | 2016-09-14 |
| Returned To Mfg | 2014-04-15 |
| Catalog Number | 7208678 |
| Lot Number | 50492240 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-14 |