MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-28 for SUPERCUT MAYO SCS 6-3/4 STR 102110 manufactured by J. Jamner Surgical Instruments.
[1442221]
The customer reports that while doing a repair of an acl the black rubbed off of the handle onto the surgeons gloved hands and destroyed the posterior tibial tendon graft that they were interesting. The graft had to be discarded and there was another graft available for use. No more than a 5-10 minute delay in the procedure. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8348322]
To date, the device involved in the reported incident has not been rec'd for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2010-00004 |
| MDR Report Key | 1592696 |
| Report Source | 06 |
| Date Received | 2010-01-28 |
| Date of Report | 2010-01-28 |
| Date Mfgr Received | 2010-01-13 |
| Date Added to Maude | 2011-03-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERCUT MAYO SCS 6-3/4 STR |
| Generic Name | NA |
| Product Code | HFG |
| Date Received | 2010-01-28 |
| Catalog Number | 102110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-28 |