MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-30 for REDUCT FORCEPS POINTS NARROW N/A 939999444 manufactured by Biomet Orthopedics.
[78915343]
(b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02428, 04479. Complaint sample was evaluated and the reported event was confirmed. Visual review of the two (2) devices returned identified that one prong on each of the forceps is fractured. Material analysis stated the following: "the clamps have scrapes and scratches but appeared as designed except for nearly identical fractured tips. Both fractures occurred at the most distal notch nearly perpendicular to the tip axis. Fracture artifacts suggest a bending overload fracture may have been initiated. The possible directions of the fractures suggest they broke during clamping. An xrf scan confirmed the material as 410/420 stainless steel. A field photo shows the clamps in the or with one of the fractured tips, which was not returned. " device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[78915344]
It is reported that the tip of two forceps fractured during a procedure. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-04479 |
| MDR Report Key | 6682175 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2016-03-15 |
| Date Added to Maude | 2017-06-30 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDUCT FORCEPS POINTS NARROW |
| Generic Name | SURGICAL INSTRUMENT, MANUAL |
| Product Code | HYA |
| Date Received | 2017-06-30 |
| Returned To Mfg | 2017-03-23 |
| Model Number | N/A |
| Catalog Number | 939999444 |
| Lot Number | 0316GH |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |