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

Model Number	N/A
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the saw attachments stops, while in use.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.
Additional Manufacturer Narrative
(b)(4) g2 ¿ foreign ¿ turkey 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 corrected information.Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because the reported event could not potentially lead to a serious injury.Given this information, this medwatch will be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because the saw attachment could not potentially lead to a serious injury.Given this information, this medwatch will be voided.

• Brand Name: 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: 18561607
• Report Number: 0008031000-2024-00020
• Device Sequence Number: 18172027
• Product Code: HAB
• UDI-Device Identifier: 00889024354944
• UDI-Public: (01)00889024354944(11)170927(10)5010363
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 89-8509-451-20
• Device Lot Number: 5010363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• 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
• Patient Sex: Prefer Not To Disclose