MAUDE Adverse Event Report: STRYKER SPINE-FRANCE POLYAXIAL SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48261330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw became bound in a patients bone and broke in the process of trying to remove it.In addition, a screwdriver also broke in the process of trying to remove the screw.
Additional Manufacturer Narrative
Catalog#: 48261330.Method: visual analysis; material analysis; device history review; complaint history review; risk assessment.Result: the customer reported event was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met specifications.Material analysis was performed on the device.No material or manufacturing defects were found.For the reported screws, tapping is recommended in most cases.It was noted that the surgeon did not tap one undersized screw hole.Conclusion: the root cause is multifactorial, screw hole preparation, under tapping, and patient bone quality being contributing factors.
Event or Problem Description
It was reported that a screw became bound in a patients bone and broke in the process of trying to remove it.In addition, a screwdriver also broke in the process of trying to remove the screw.

• Brand Name: POLYAXIAL SCREWDRIVER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6992888
• Report Number: 0009617544-2017-00393
• Device Sequence Number: 1548545
• Product Code: LXH
• UDI-Device Identifier: 07613327353167
• UDI-Public: (01)07613327353167
• 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): 01/25/2018

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 Model Number: 48261330
• Device Catalogue Number: 48268011
• Device Lot Number: 172092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1