MAUDE Adverse Event Report: ZIMMER GMBH EXTRACTOR WITH SLIDING HAMMER; HIP, INSTRUMENTS

Catalog Number	0106808300
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: report source canada.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 avenir slap hammer broke during use, no parts fell into patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Corrected: h8.No product was returned for evaluation.The visual examination of the provided picture shows the threaded section exhibiting what appears to be damage to the threads however the quality of the photograph is poor and no further statement can be made.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Based on the available information, the reported event can be confirmed a definitive root cause could not 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The reported product was returned to the product surveillance team for examination.The thread of the tip of the rod (attachment to the stem) is deformed and damaged.The thread of the connection rod to the smaller rod is inconspicuous.The outcome of the investigation remains unchanged.Based on the available information, a definitive root cause could not 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: EXTRACTOR WITH SLIDING HAMMER
• Common Device Name: HIP, INSTRUMENTS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21698680
• Report Number: 0009613350-2025-00191
• Device Sequence Number: 9419405
• Product Code: LZO
• UDI-Device Identifier: 00889024288669
• UDI-Public: (01)00889024288669(10)4505049263
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193030
• 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): 11/18/2025

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: 0106808300
• Device Lot Number: 4505049263
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 11/18/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/11/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown