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

Catalog Number	11-3583
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
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.E1 telephone number: (b)(6).G2 country: japan.
Event or Problem Description
It was reported that during inspection the device had a hair-like substance inside the packaging.There was no patient involvement.Due diligence is complete and there is no additional information available.
Event or Problem Description
There is no additional information regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d4, d9, e2, g1, g3, g6, h1, h2, h3, h4, h5, h6, h10, and h11.Package of blade was returned unopened.Visual inspection did find a hair-like debris sealed inside the packages.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event was confirmed.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.

• 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: 23278378
• Report Number: 0001526350-2025-01309
• Device Sequence Number: 12975220
• Product Code: GFA
• UDI-Device Identifier: 00889024494015
• UDI-Public: (01)00889024494015(17)300729(10)476943
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 11-3583
• Device Lot Number: 476993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown