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 Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hybrid fixation pin that was being used to hold the plate in place broke off in the patient.It was removed with a screw removal set.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported that a hybrid fixation pin that was being used to hold the plate in place broke off in the patient.It was removed with a screw removal set.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Device was not returned, therefore device evaluation could not be completed.As such, there is no conclusion of the cause of the event.Since the lot number is unknown, no manufacturing records could not be reviewed.Possible root causes are hard bone quality of the patient, full pin tip, 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.

• 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
• MDR Report Key: 7558621
• Report Number: 0009617544-2018-00115
• Device Sequence Number: 16459230
• Product Code: LXH
• UDI-Device Identifier: 07613327270761
• UDI-Public: (01)07613327270761
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/28/2018

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: No Information
• Device Model Number: 48510420
• Device Catalogue Number: 48510420
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1