MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 LE NITINIOL KWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48280232
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the k wire broke off in patient pedicel while using tap to prepare hole for screw.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the instrument broke during tapping.The handle was deformed.The k-wire has a small geometry that allows for instruments to slide over the k-wire and be guided into the correct trajectory within the wound.As a result, as excessive force (i.E.Axial force, torsional force) is applied during tapping, it may have caused an increased stress concentration at the connection point between the handle and the k-wire and ultimately resulted in the breakage.Conclusion: the possible root cause of the reported issue may be related to excessive force applied during tapping to prepare the screw pathway.
Event or Problem Description
It was reported that the k wire broke off in patient pedicel while using tap to prepare hole for screw.

• Brand Name: ES2 LE NITINIOL KWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5486485
• Report Number: 0009617544-2016-00103
• Device Sequence Number: 498493
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• 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): 02/12/2016

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: 48280232
• Device Lot Number: 158099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 05/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1