MAUDE Adverse Event Report: STRYKER SPINE-US PARALLEL POST DISTRACTOR, XIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2704XLP
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	02/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: post screw head distracter broke.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met stryker specifications.Device was manufactured in may 2013.The most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported: post screw head distracter broke.

• Brand Name: PARALLEL POST DISTRACTOR, XIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6399498
• Report Number: 3004024955-2017-00015
• Device Sequence Number: 798233
• Product Code: LXH
• UDI-Device Identifier: 07613327142174
• UDI-Public: (01)07613327142174
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/18/2017

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: IS2704XLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1