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

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	12/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the medial arm broke during surgery.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: the device was not returned for evaluation after and manufacturing review of the reported lot found no relevant issues were identified.
Event or Problem Description
It was reported that the medial arm broke during surgery.

• Brand Name: PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6205913
• Report Number: 0009617544-2016-00503
• Device Sequence Number: 709796
• Product Code: LXH
• UDI-Device Identifier: 07613327135473
• UDI-Public: (01)07613327135473
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/21/2017

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: 145927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1