MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0MM TI W/ MAXBRAID NO NDLS; SCREW, FIXATION, BONE/SPORTS MEDICINE

Catalog Number	902572
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: denmark.H3: 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.
Event or Problem Description
It was reported that while the surgeon was inserting the implant into the patient's rotator cuff, the implant fractured.There was no report of foreign body retained or harm to the patient.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.The following sections were corrected: d4; h4.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that while the surgeon was attempting to insert the implant into the patient's rotator cuff, the implant fractured.All pieces and fragments of the implant were removed from the patient.There was no foreign body retained or harm to the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The following section was corrected: d9.Visual examination of the returned product/provided pictures identified signs of use with some staining on the sutures and on the handle of the device.The anchor has fractured, and not all of the pieces were returned with the device.Part of the anchor remains in the handle of the device.The returned device was reviewed with scanning electron microscopy.Fracture surface artifacts of sheared ductile dimples suggest the bending overload mode of failure.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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
• Common Device Name: SCREW, FIXATION, BONE/SPORTS MEDICINE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21833901
• Report Number: 0001825034-2025-01078
• Device Sequence Number: 4210784
• Product Code: HWC
• UDI-Device Identifier: 00880304404328
• UDI-Public: (01)00880304404328(17)280412(10)0002513633
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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 Catalogue Number: 902572
• Device Lot Number: 0002513633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 09/30/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 04/28/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown