MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID TEMPORARY FIXATION PIN LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48510420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pin of a reflex hybrid temporary fixation pin broken off of the instrument during cleaning outside of the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients or surgical delays were seen.
Additional Manufacturer Narrative
Field d4 has been corrected from '189890' to '180890'.A visual inspection was performed, it was observed that the fixation pin is fractured at the shaft as reported.Device and complaint history records were for this lot were reviewed, no relevant manufacturing issues or similar complaints were identified.This device was manufactured in 2018, over 4 years ago.The reflex-hybrid surgical technique warns users to load the pin into the quick release pin inserter when inserting it.It is advised to place 2 pins diagonally from one another to stabilize the plate however excessive pivoting or angulation on the pin inserter should be avoided.The plausible root cause of the reported event could not be determined conclusively as it is unknow how/when the device fractured.Factors that may have contributed to fracture: normal wear and tear, hard bone quality of the patient, applying too much compressive torque on the inserter, not using the fixation pin inserter, or inserting the pin at an angle outside the specified range could lead to the failure mode of the device.
Event or Problem Description
It was reported that the pin of a reflex hybrid temporary fixation pin broken off of the instrument during cleaning outside of the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients or surgical delays were seen.

• Brand Name: REFLEX-HYBRID TEMPORARY FIXATION PIN LONG
• 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: 13869777
• Report Number: 0009617544-2022-00036
• Device Sequence Number: 5295638
• Product Code: LXH
• UDI-Device Identifier: 07613327270761
• UDI-Public: 07613327270761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 48510420
• Device Catalogue Number: 48510420
• Device Lot Number: 180890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2018
• 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