MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SAW BLADES LINVATEC®/HALL® POWER SYSTEMS; SURGICAL SAW BLADE, OSCILLATING, SINGLE-USE

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01666.0001526350-2023-01667.
Event or Problem Description
It was reported by the distributorship that the products were found to be nonconforming.There were wrinkles in the sealing area.There was no patient involvement.Due diligence is complete, there is no additional information available.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported since the wrinkles in ln 426749 were not raised and did not appear to compromise the seals.This medwatch is being voided.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported since the wrinkles in ln 426749 were not raised and did not appear to compromise the seals.This medwatch is being voided.

• Brand Name: SAW BLADES LINVATEC®/HALL® POWER SYSTEMS
• Common Device Name: SURGICAL SAW BLADE, OSCILLATING, SINGLE-USE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18357120
• Report Number: 0001526350-2023-01668
• Device Sequence Number: 20531679
• Product Code: GFA
• UDI-Device Identifier: 00889024494015
• UDI-Public: (01)00889024494015(17)280412(10)426749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/31/2024

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: 11-3583
• Device Lot Number: 426749
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose