MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT SHORT RIGID SZ1 IMP/DRL; TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE

Catalog Number	110005307
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.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 the tip of the device was already bent prior to use.No patient harm.Attempts have been made and additional information on the reported event is unavailable at this time.
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, h2, h3, h6, h11.H6: proposed component code: mechanical (g04) - drill.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified the rigid drill is bent and does have some unknown debris around the edge of the point at the distal end of the drill.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as manufacturing deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Attempts have been made and no further information has been provided.

• Brand Name: JGRKNT SHORT RIGID SZ1 IMP/DRL
• Common Device Name: TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE
• 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: 23511528
• Report Number: 0001825034-2025-03548
• Device Sequence Number: 9733261
• Product Code: MBI
• UDI-Device Identifier: 00880304568198
• UDI-Public: (01)00880304568198(17)290806(10)0002659255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110145
• 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
• Report Date (Section B): 03/26/2026

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: 110005307
• Device Lot Number: 0002659255
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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