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

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2- turkey investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during surgery reciprocating saw attachment stopped and did not work again.Surgery was completed with alternative device.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d1, g3, g6, h2, h3, h6, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.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 complaints for the reported part and serial combination.A definitive root cause cannot be determined.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
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 CH-12 28; SZ CH-1228
• 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: 18825974
• Report Number: 0008031000-2024-00072
• Device Sequence Number: 3047672
• Product Code: HAB
• UDI-Device Identifier: 00889024354944
• UDI-Public: (01)00889024354944(11)190830(10)5012759
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 07/23/2024

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 Model Number: N/A
• Device Catalogue Number: 89-8509-451-20
• Device Lot Number: 5012759
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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: Prefer Not To Disclose