MAUDE Adverse Event Report: ZIMMER BIOMET, INC. THREADED TIP STEINMANN PIN; SURGICAL INSTRUMENT HANDLE, NON-TORQUE-LIMITING

Catalog Number	406669
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the steinmann pin was noted to be broken due to a mistake by the surgeon with the surgical technique.It was noted the pin was wrongly directed into the hole of the guide when it broke.No patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 407396; lot# 347810.G2: foreign - event occurred in spain.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 which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the provided picture identified the pin shown matches the print of the reported part number.The reported fracture is not visible.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Per the device's surgical technique: place two threaded steinman pins through converging angled holes in the resection guide block and into the bone to secure the block to the bone.In order to secure and remove the block to/from the bone, the pins should be placed and removed at a corresponding angle to the holes.As it was reported that the pin broke during removal as a result of being placed through the guide at an incorrect angle/direction, the user did not follow instructions.The event was unable to be confirmed if any further information 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
No further event information available at the time of this report.

• Brand Name: THREADED TIP STEINMANN PIN
• Common Device Name: SURGICAL INSTRUMENT HANDLE, NON-TORQUE-LIMITING
• 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: 23315796
• Report Number: 0001825034-2025-03257
• Device Sequence Number: 14906660
• Product Code: LXH
• UDI-Device Identifier: 00887868505232
• UDI-Public: (01)00887868505232(17)350425(10)67301232
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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): 04/29/2026

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: 406669
• Device Lot Number: 67301232
• Was Device Available for Evaluation?: No
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Patient Sex: Unknown