MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0MM TI W/ MAXBRAID NO NDLS E SUT; PROSTHESIS, SPORTS MED

Catalog Number	902572
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in (b)(6).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.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
It was reported approximately four (4) weeks ago during a rotator cuff repair surgery, the device failed to advance through the cortex.The surgeon tried two (2) devices, one (1) broke and one (1) bent.There was a thirty (30) minute delay while the surgeon located and removed the broken part from the patient.Surgeon used a third device to complete the surgery with no issues.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d9; g3; g6; h1; h2; h3; h6 visual examination of the returned product identified the screws have either been bent or fractured.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 available at the time of this report.

• Brand Name: 5.0MM TI W/ MAXBRAID NO NDLS E SUT
• Common Device Name: PROSTHESIS, SPORTS MED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10717396
• Report Number: 0001825034-2020-03865
• Device Sequence Number: 3433254
• Product Code: HWC
• UDI-Device Identifier: 00880304404328
• UDI-Public: (01)00880304404328
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 03/22/2021

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: 12/13/2024
• Device Catalogue Number: 902572
• Device Lot Number: 504180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 03/22/2021
• 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: NI
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77