MAUDE Adverse Event Report: STRYKER SPINE-US PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48760631C
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the securing mechanism of a lite pedicle base retractor medial arm assembly was "spinning in the void" intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the device laser markings were slightly worn and main body was discolored.The edges of the angulation adjustment hex were worn and rounded out.Functional inspection: the device was able to translate and release as intended.The device was able to adjust angularly; however, the driver mated loosely to the angulation adjustment hex.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.The instructions for use advises the user to lubricate the device as needed to ensure proper functionality.The life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Review of manufacturing records reveal that the device was about 3 years old at the time of complaint.It is likely that repeated cantilever and torsional loading throughout the device's service life could have compromised the material integrity of the device, causing wear of the hex.
Event or Problem Description
It was reported that the securing mechanism of a lite pedicle base retractor medial arm assembly was "spinning in the void" intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10385032
• Report Number: 0009617544-2020-00135
• Device Sequence Number: 2898498
• Product Code: LXH
• UDI-Device Identifier: 07613327135473
• UDI-Public: 07613327135473
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 48760631C
• Device Catalogue Number: 48760631C
• Device Lot Number: 151683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1