MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. OSCILLATING SAW BLADE CUTTING: 90MM L X 20MM W X 1.19MM THICK; SURGICAL SAW BLADE, OSCILLATING, SINGLE-USE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Phone number: (b)(6).Foreign (china).The blade was returned with the outer package opened, but the inner packaging was still sealed with the blade inside.Visual inspection confirmed the outer packaging had a small perforation that went all the way through to the inner packaging and compromised the sterilization of the product.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is 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.
Event or Problem Description
It was reported that outside of surgery the sterile package was broken at the distributor.There was no patient involvement and no impact to patient and/ or user.Due diligence information complete.No additional event information available.During evaluation, it was discovered that the outer packaging had a small perforation that went all the way through to the inner packaging and compromised the sterilization of the product.

• Brand Name: OSCILLATING SAW BLADE CUTTING: 90MM L X 20MM W X 1.19MM THICK
• 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: 17180896
• Report Number: 0001526350-2023-00616
• Device Sequence Number: 20441466
• Product Code: GFA
• UDI-Device Identifier: 00889024496064
• UDI-Public: (01)00889024496064(11)220718(17)270718(10)409939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 20090119AGC
• Device Lot Number: 409939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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