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

Catalog Number	48280232
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	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tlif surgery, a short blade screw was inserted via k-wire without any problems.However, it was found by post operative radiograph that a part of the k-wire was being left in s1.The fragment of k-wire was not retrieved.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via email correspondence with the sales rep.The product was discarded and lot# not provided.It was reported that the awl was not used to prepare the pedicle.The k-wire guide tube was not used to insert the k-wire.The k-wire was inserted via j-probe outer tube the k-wire was properly held in position while removing the outer shaft of the needle.The k-wire was properly held in position while removing the dilator.It is unknown is a tip of the k-wire pinched during the insertion of an awl.The device surgical technique recommends that the awl is used to create a pilot hole prior to tapping.Conclusion: the most likely root cause of the reported event it is non-use of awl to prepare the pedicle.
Event or Problem Description
It was reported that during tlif surgery, a short blade screw was inserted via k-wire without any problems.However, it was found by post operative radiograph that a part of the k-wire was being left in s1.The fragment of k-wire was not retrieved.No adverse consequences to the patient is reported.

• Brand Name: ES2 LE NITINIOL KWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7908547
• Report Number: 0009617544-2018-00232
• Device Sequence Number: 1449678
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• 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): 11/21/2018

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 Catalogue Number: 48280232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1