MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.0MM TI W/ MAXBRAID NDLS; SPORTSMED, IMPLANTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 902569; lot# 533560; 3.0mm ti w/ maxbraid ndls.Foreign: the event occurred in (b)(6).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.Product not returned.
Event or Problem Description
It was reported that one anchor bent and another fractured during the surgery.The fractured piece of the anchor was removed from the patient's body.There was a delay of 16-30 minutes.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d4 the following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 visual examination of the returned product identified the anchor is fractured.Item and lot numbers were not confirmed as they were not etched on the part.Sem analysis of the maxbraid needle anchor using an optical microscope showed that it fractured due to torsional overload.The direction of crack propagation and crack exit area identified on the fracture surface, indicated a possible torsional overload mode of failure.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3.0MM TI W/ MAXBRAID NDLS
• Common Device Name: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11723792
• Report Number: 0001825034-2021-01044
• Device Sequence Number: 3193048
• Product Code: MBI
• UDI-Device Identifier: 00880304432093
• UDI-Public: (01)00880304432093(17)250826(10)533560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 902569
• Device Lot Number: 533560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1