MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETRACTOR 1; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00780600510, retractor, 1-62219387.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02308.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.

Event Description

It was reported that the tips broke on the retractors during surgery.All of the pieces were retrieved.No delay to the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual review of retractors identified the following: the tip had fractured and the fractured piece was not returned.There were nicks and gouges consistent with use on the tips of these instruments.Retractor (ln 64533728) has a potential field age of approximately 4 months, and retractor (ln 62219387) has a potential field age of approximately 7.5 years.Review of the zimmer biomet's device history records and receiving inspection report identified no deviations or anomalies during manufacturing.Supplier's device history records were not reviewed as the devices exhibit wear and tear consistent with use over a field age of 4 months, and 7.5 years respectively.Additionally, review of the raw material certificate in the rir confirmed that the materials utilized were conforming to specifications.A definitive root cause cannot 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: RETRACTOR 1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10216825
• MDR Text Key: 199507626
• Report Number: 0001822565-2020-02306
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00780600510
• Device Lot Number: 64533728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1