MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL PIN AND SCREW INSERTER; PROTHESIS KNEE

Catalog Number 00590102100

Device Problem Fracture (1260)

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

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that the pin driver broke while extracting pins.No adverse event was reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned device identified that the instrument exhibited a fracture at the hex end of the instrument.Sem analysis of the fracture surface identified the fracture occurred due to bending overload.The fracture surface revealed multiple crack initiation sites near the inner diameter of the pin driver and that cracks propagated towards its outer diameter.Surgical notes were not provided.The device history records receiving inspection reports were reviewed for deviations and/or anomalies with no deviations or anomalies identified.A definitive root cause cannot be determined as the frequency and conditions of use are unknown 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.

Event Description

No further event information available at the time of this report.

• Brand Name: DRILL PIN AND SCREW INSERTER
• Type of Device: PROTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7642535
• MDR Text Key: 112489202
• Report Number: 0001822565-2018-03372
• Device Sequence Number: 1
• Product Code: HWB
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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 Catalogue Number: 00590102100
• Device Lot Number: 63530770
• Other Device ID Number: (01) 00889024201637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 86