MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-30 for MB & J NO BOUNCE MALLET N/A 740042 manufactured by Biomet Orthopedics.
[1241222]
It was reported that patient underwent total hip arthroplasty utilizing a mallet in 2009. During the procedure, the mallet broke open, and the interior contents spilled into the patient's wound. The site was cleaned and radiographs were taken and read as negative. The patient was also given extra antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[1393067]
It was reported that patient underwent total hip arthroplasty utilizing a mallet on (b) (6) 2009. During the procedure, the mallet broke open and the interior contents spilled into the patient's wound. The site was cleaned and radiographs were taken and read as negative. The patient was also given extra antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[8370012]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records shows that lot released with no recorded anomaly or deviation. There have been no trends identified related to this type of event. This report filed september 30, 2009.
Patient Sequence No: 1, Text Type: N, H10
[8501501]
The exact root cause of the reported breakage could not be confirmed, wear from extensive use may have been a contributing factor. The device was manufactured in november of 1993. There are warnings in the package insert that state 'surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. ' there are no implications to the patient as radiographs did not identify any foreign material retention. No patient injury has been reported. The contents of the mallet are made from stainless cut wire shot. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2009-00219 |
| MDR Report Key | 1486650 |
| Report Source | 07 |
| Date Received | 2009-09-30 |
| Date of Report | 2009-09-01 |
| Date of Event | 2009-09-01 |
| Date Mfgr Received | 2009-09-01 |
| Device Manufacturer Date | 1993-11-03 |
| Date Added to Maude | 2009-12-15 |
| 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 | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MB & J NO BOUNCE MALLET |
| Generic Name | MALLET, ORTHOPEDIC |
| Product Code | HXL |
| Date Received | 2009-09-30 |
| Model Number | N/A |
| Catalog Number | 740042 |
| Lot Number | 124080 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-30 |