MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-02-22 for KMEDIC MALLET WITH NYLON CAPS KM46662 manufactured by Teleflex.
[2494643]
The event is reported as: complaint alleges: the nylon end of this mallet came off during surgery. No pieces fell into the patient and both pieces were retrieved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9604689]
A visual examination of the actual product revealed the end caps were yellowed and cracking. One end is broken off and the thread portion is still stuck in the mallet. Root cause is device was used beyond useful life. Replacement caps are sold for this instrument to replace worn or damaged heads. The broken head is a result of incomplete inspection by the user before use. The fractures on the nylon cause should have been cause for replacement. The instrument was repaired rather than replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00005 |
| MDR Report Key | 2476051 |
| Report Source | 06,07 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-01-31 |
| Date Mfgr Received | 2012-02-10 |
| Date Added to Maude | 2012-08-22 |
| 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 | ELAINE BURKLE, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KMEDIC MALLET WITH NYLON CAPS |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2012-02-22 |
| Returned To Mfg | 2012-02-07 |
| Catalog Number | KM46662 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-22 |