MAUDE Adverse Event Report: STRYKER SPINE-FRANCE PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	48760631C
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; medial arm of retractor broke and rendered useless."pulling" mechanism of medial arm screw broke and made the arm unable to lock in place when retracted medially.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; no relevant manufacturing issues were identified for the reported lot as all units met stryker specifications.Securing mechanism fracture was confirmed via correspondence with the sales rep and visual inspection of the returned device.The plausible root cause of the reported event cannot be identified conclusively as not all the pieces of the device were returned for evaluation.
Event or Problem Description
It was reported that; medial arm of retractor broke and rendered useless."pulling" mechanism of medial arm screw broke and made the arm unable to lock in place when retracted medially.

• Brand Name: PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6087094
• Report Number: 0009617544-2016-00444
• Device Sequence Number: 857988
• Product Code: GAD
• UDI-Device Identifier: 07613327135473
• UDI-Public: (01)07613327135473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/12/2017

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 Catalogue Number: 48760631C
• Device Lot Number: 155341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1