MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0MM 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	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the anchor fractured during insertion.All the broken parts were retrieved from the patient's body.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 updated/corrected.Updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.Corrected: d4: expiration date.The event was confirmed with product received.Visual examination of the returned product confirmed the anchor had fractured and all the pieces were returned.Sem analysis of the maxbraid needle anchor showed that it fractured due to sheared overload.Suspected crack initiation region identified on the fracture.Fine sheared ductile overload dimples identified in the non-smeared areas in the suspected crack initiation region on the fracture.The sheared ductile overload dimples revealed the direction crack propagation/smearing.Center of the fracture revealed fine ductile overload normal dimples, which are indicative of a possible tensile overload mode for crack exit.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 5.0MM 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: 11462701
• Report Number: 0001825034-2021-00578
• Device Sequence Number: 16941757
• Product Code: MBI
• UDI-Device Identifier: 00880304009677
• UDI-Public: (01)00880304009677(17)250624(10)539440
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 06/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 902571
• Device Lot Number: 539440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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