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 2020-03-28 for TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL 72202595 manufactured by Smith & Nephew, Inc..
[186231109]
It was reported that during an achilles tendon repair surgery, the anchor slipped out and it can't screw-in. It is unknown if there was an available backup device or a significant delay during the procedure. No patient injury or other complications were reported. Results of investigation have concluded that unit threads were damaged (burnished and scalloped) which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2020-00560 |
| MDR Report Key | 9894923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-01-11 |
| Date Added to Maude | 2020-03-28 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| 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 | TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 72202595 |
| Catalog Number | 72202595 |
| Lot Number | 2025331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-28 |