MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2009-01-07 for 6.5MM ALLTHREAD TITANIUM SUTURE ANCHOR 902613 manufactured by Biomet Sports Medicine.
[981965]
While inserting the anchor, it became detached from the handle inserter. The surgeon was forced to go from an arthroscopic procedure to a mini-open in order to retrieve the anchor. This caused the case to be extended approximately 1 hour.
Patient Sequence No: 1, Text Type: D, B5
[8202952]
Evaluation summary: the investigation revealed that the punch technique was used prior to inserting the implant. Allthread titanium suture anchors require pre-drilling prior to insertion. The punch technique appears to have fractured the implant and driver at the male to female hex. Upon excessive torque, the fracture weakened and broke. Package insert warning # 8 states; do not use excessive force when inserting the anchor. Excessive force (e. G. Long hard hammer blows) may cause fracture or bending of the device. Prior to insertion of the implant, predrill, awl or tap.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027970-2008-00039 |
| MDR Report Key | 1281651 |
| Report Source | 07,08 |
| Date Received | 2009-01-07 |
| Date of Report | 2008-12-09 |
| Date of Event | 2008-11-05 |
| Date Mfgr Received | 2008-12-09 |
| Device Manufacturer Date | 2008-10-27 |
| Date Added to Maude | 2009-02-06 |
| 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 Street | 4861 EAST AIRPORT DRIVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9093900356 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6.5MM ALLTHREAD TITANIUM SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2009-01-07 |
| Model Number | 902613 |
| Catalog Number | 902613 |
| Lot Number | L074710 |
| ID Number | NA |
| Device Expiration Date | 2013-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | ONTARIO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-07 |