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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during receiving inspection debris was found in the sterile package.There was no harm or injury to patient as there was no patient involvement.Due diligence is complete and no additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual inspection confirmed there were specs of white debris, measuring between.25mm -.15mm squared, inside the sealed package of the blades.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to manufacturing deficiencies.The event is confirmed.G2, country event occurred in: japan.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 additional information is available regarding the incident.

• 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: 17001443
• Report Number: 0001526350-2023-00501
• Device Sequence Number: 6343914
• Product Code: GFA
• UDI-Device Identifier: 00889024494015
• UDI-Public: (01)00889024494015(17)280307(10)424633
• 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): 11/14/2023

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: 424633
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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