MAUDE Adverse Event Report: STRYKER SPINE-US ZERO PROFILE PLATE HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48513010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside of the or the locking mechanism of a dynatran zero profile plate holder was broken.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The issue was confirmed upon visual inspection of the returned device.The securing mechanism is fractured.The instrument was tested and confirmed not to remain locked, therefore is no longer functional.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history was reviewed and no previous complaints for this lot were found.Based on provided information the device damage occurred most likely during cleaning, sterilization, handling after the surgery or after the cleaning, however a definite cause cannot be determined as it is unknown when the damage occurred.
Event or Problem Description
It was reported that outside of the or the locking mechanism of a dynatran zero profile plate holder was broken.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: ZERO PROFILE PLATE HOLDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12643451
• Report Number: 0009617544-2021-00207
• Device Sequence Number: 4343904
• Product Code: LXH
• UDI-Device Identifier: 07613327270990
• UDI-Public: 07613327270990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 48513010
• Device Catalogue Number: 48513010
• Device Lot Number: 203245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• 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: Unknown