MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA PRECISION K WIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48230231
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open surgery, the surgeon inserted a screw without a k-wire after the tapping.But the screw did not proceed along the orbit of the tap.Then, the surgeon was inserted the same screw through the k-wire again.But the k-wire was bent excessively and stacked in the screw.The surgeon used a new k-wire and a new screw, and progressed the surgery.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: it is likely that the screw cannula deformed when the surgeon initially tried to insert the screw without the k-wire and was unable to do so.When he tried to insert the same screw using a k-wire, it is likely that the damaged screw cannula prevented the k-wire to pass through it, resulting the reported jamming.Conclusion: the probable root cause of this event is user error.
Event or Problem Description
It was reported that during an open surgery, the surgeon inserted a screw without a k-wire after the tapping.But the screw did not proceed along the orbit of the tap.Then, the surgeon was inserted the same screw through the k-wire again.But the k-wire was bent excessively and stacked in the screw.The surgeon used a new k-wire and a new screw, and progressed the surgery.

• Brand Name: XIA PRECISION K WIRE 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: 5821061
• Report Number: 0009617544-2016-00302
• Device Sequence Number: 18837849
• Product Code: LXH
• UDI-Device Identifier: 07613327265286
• UDI-Public: (01)07613327265286
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

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: 48230231
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1