MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-12-27 for XCEL HIGH STRENGTH SUTURE ANCHOR (5BX) * 3910300015 manufactured by Stryker Endoscopy San Jose.
[424764]
Metal inserter broke off into anchor. Metal rod is now inside anchor that was inserted into pt.
Patient Sequence No: 1, Text Type: D, B5
[7796719]
The unit has arrived and the failure is confirmed. One metal support on the distal tip of the inserter shaft is broken off. The bend in the remaining metal support indicates high torsional force. Rotation of the shaft during implantation isnot instructed in the product ifu. The other unit returned also shows signs of torsional force. Attempting to insert the anchor into an undersized hole could cause this failure. Without details of surgery procedure and product usuage, the exact root cause cannot be determined. The assumed root cause is product misuse. This failure has never been seen in the field before and never been seen during product testing under proper usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2005-00080 |
| MDR Report Key | 657832 |
| Report Source | 05 |
| Date Received | 2005-12-27 |
| Date of Report | 2005-12-02 |
| Date of Event | 2005-12-02 |
| Date Mfgr Received | 2005-12-02 |
| Date Added to Maude | 2006-01-03 |
| 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 | 0 |
| Manufacturer Contact | BETH ONDERLINDE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XCEL HIGH STRENGTH SUTURE ANCHOR (5BX) |
| Generic Name | FIXATION DEVICE |
| Product Code | NOV |
| Date Received | 2005-12-27 |
| Returned To Mfg | 2005-12-07 |
| Model Number | * |
| Catalog Number | 3910300015 |
| Lot Number | 675793 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 647305 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | * SAN JOSE CA 95138 US |
| Baseline Brand Name | XCEL HIGH STRENGTH SUTURE ANCHOR (5BX) |
| Baseline Generic Name | FIXATION DEVICE |
| Baseline Model No | * |
| Baseline Catalog No | 3910300015 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-27 |