MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID PLATE BENDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48510200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that a reflex hybrid plate bender broke when attempting to bend the plate.Surgery was successfully completed and no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that a reflex hybrid plate bender broke when attempting to bend the plate.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information: b.5.Updated with delay time.
Additional Manufacturer Narrative
One of the prongs on the back of device is fractured.Material wear and discoloration identified on the device.The device is no longer functional.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaint were identified.This device is approximately 17 years old.The root cause of the reported event is fracture due to normal wear and tear.Factors such as consistent use, cleaning, sterilization of the instrument throughout its lifetime may have caused fatigue and contribute to the fracture.
Event or Problem Description
It was reported that a reflex hybrid plate bender broke when attempting to bend the plate.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: REFLEX-HYBRID PLATE BENDER
• 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: 13061105
• Report Number: 0009617544-2021-00239
• Device Sequence Number: 1506198
• Product Code: LXH
• UDI-Device Identifier: 07613327270808
• UDI-Public: 07613327270808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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: 48510200
• Device Catalogue Number: 48510200
• Device Lot Number: 051223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/28/2022; 03/16/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/24/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2005
• 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