MAUDE Adverse Event Report: STRYKER SPINE-US DYNATRAN ACP DISTRACTION PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48515021
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dynatran distraction pin 'deformed' intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.The system offers custom distraction pins that allow dynatran plates to be positioned with the pins still in place to facilitate plate alignment and soft tissue retraction.The dynatran® distraction pin, designed for use with the reliance® c cervical instrumentation set, can be used to facilitate plate placement.The distraction pins (12mm) are designed without a flange so that the plate can be positioned closer to the pins.In this way, the pins can be used as a soft tissue retractor, a visual cue to the midline, and to help stabilize the plate.To use the distraction pins to facilitate plate stabilization, place the distraction pins approximately 6.5mm to 8mm from the end plates.Remove one pin if necessary and rotate the plate around the pin to facilitate alignment.The root cause of the reported event cannot be determined conclusively from the information provided and without device inspection.H3 other text : hospital disposed of device.
Event or Problem Description
It was reported that a dynatran distraction pin "deformed" intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.

• Brand Name: DYNATRAN ACP DISTRACTION PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11807676
• Report Number: 0009617544-2021-00080
• Device Sequence Number: 3646316
• Product Code: LXH
• UDI-Device Identifier: 07613327008258
• UDI-Public: 07613327008258
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/07/2021

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: 48515021
• Device Catalogue Number: 48515021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1