MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-06-25 for FAST-FIX AB ASSEMBLY - CURVED 7209399 manufactured by Mansfield Manufacturing Site.
[19532329]
During surgery, the implant stayed in the patient but the suture broke. The implants were all left in the body, each failed occurring at the point when the surgeon pulled to tighten the knot prior to putting the pusher cutter in the knee. This was an experienced surgeon who successfully put 6 fast-fix in the same person. The failure occurred right at the to, when he pulled, the suture broke at the to and left them both in knee for each of the 3 failures. Back up devices were on hand.
Patient Sequence No: 1, Text Type: D, B5
[19665654]
Device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2009-00193 |
| MDR Report Key | 1478695 |
| Report Source | 06,07 |
| Date Received | 2009-06-25 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-05-28 |
| Date Facility Aware | 2009-06-01 |
| Report Date | 2009-06-25 |
| Date Mfgr Received | 2009-06-01 |
| Device Manufacturer Date | 2009-02-10 |
| Date Added to Maude | 2009-10-30 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 FORBES BLVD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | MANSFIELD MANUFACTURING SITE |
| Manufacturer Street | 130 FORBES BLVD. |
| 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 | FAST-FIX AB ASSEMBLY - CURVED |
| Generic Name | FAST-FIX AB ASSEMBLY - CURVED/KGS |
| Product Code | KGS |
| Date Received | 2009-06-25 |
| Model Number | 7209399 |
| Catalog Number | 7209399 |
| Lot Number | 50281816 |
| Device Expiration Date | 2014-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANSFIELD MANUFACTURING SITE |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-25 |