MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL RECIP SAW ATTACH; BURRING POWER TOOL ATTACHMENT

Catalog Number	89-8509-451-20
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reciprocating saw has stopped during surgery.It was necessary to knock on the handpiece's battery to get it worked again.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - associated products: unknown universal handpiece; item# unknown; lot# unknown; serial# unknown.Unknown universal battery; item# unknown; lot# unknown; serial# unknown.G2 - foreign: france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10 - associated products: universal mod elec/batt dbl trig hp; item# 89-8507-400-00; lot # 5012241, serial# (b)(6) universal battery for atk; item# 89-8510-440-20; serial# (b)(6) universal aseptic transfer kit housing; item# 89-8510-440-10; lot# 5012250 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, d10, h1, h2, h3, h6, h11 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Review of the most recent repair record determined the reported issue could not be duplicated; however, the blade locking mechanism was worn and was malfunctioning.The device was returned unrepaired.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and serial combination.With given information, a definitive root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UNIVERSAL RECIP SAW ATTACH
• Common Device Name: BURRING POWER TOOL ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21025092
• Report Number: 0008031000-2024-00213
• Device Sequence Number: 13038326
• Product Code: HAB
• UDI-Device Identifier: 00889024354944
• UDI-Public: (01)00889024354944
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 89-8509-451-20
• Device Lot Number: 5010596
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 07/01/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/14/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE UPDATED.; SEE NARRATIVE IN H11.
• Patient Sex: Unknown