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

Model Number	48510420
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reflex-hybrid fixation pin and screw extractor inner shaft were observed to be bent outside the operating room.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report will capture the pin.
Event or Problem Description
It was reported that a reflex-hybrid fixation pin and screw extractor inner shaft were observed to be bent outside the or.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report will capture the pin.
Additional Manufacturer Narrative
The event was confirmed via visual inspection of the returned device.Manufacturing history was reviewed and no issues were identified.The lot was manufactured in october of 2018.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.No additional information was provided from a complainant.The cause of the reported event cannot be determined from the information provide.Potential causes include: application of excessive force, excessive pivoting or angulation, 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.

• 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: 13577966
• Report Number: 0009617544-2022-00019
• Device Sequence Number: 19936000
• Product Code: LXH
• UDI-Device Identifier: 07613327270761
• UDI-Public: 07613327270761
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 18303E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2018
• 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