MAUDE Adverse Event Report: BIOMET TRAUMA REDUCT FORCEPS POINTS NARROW; SURGICAL INSTRUMENT, MANUAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Quantity: 2.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 & 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 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.

• Brand Name: REDUCT FORCEPS POINTS NARROW
• Type of Device: SURGICAL INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6462377
• MDR Text Key: 72098824
• Report Number: 0001825034-2017-02428
• Device Sequence Number: 1
• Product Code: HYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 939999444
• Device Lot Number: 0316GH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided; 06/27/2017
• Supplement Dates FDA Received: 05/11/2017; 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1