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

Model Number	48280232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portion of an es2 kwire broke off inside the patient intra-operatively.The patient was revised the next day in order to remove the fractured piece and the procedure was completed successfully with an unspecified surgical delay.
Additional Manufacturer Narrative
Visual: visual inspection confirmed that k-wire distal tip had fractured off.The fractured tip was discolored and ~25mm long.Fracture occurred where k-wire was bent.K-wire was straight until fracture location.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The two ends of the fractured sections of k-wire were bent, indicating that excessive force may have been applied to k-wire either during insertion or removal.Bending also could indicate that excessive force or cantilevering of the awl and taps may have been applied.The bend of the k-wire indicates that there was excessive force applied specifically to that location to cause fracture to occur.If bent during tapping, the screw may have caused the event to occur during insertion, as well.The most likely root cause of the even was determined to be excessive force and/or cantilevering of the taps applied during tapping.
Event or Problem Description
It was reported that a portion of an es2 kwire broke off inside the patient intra-operatively.The patient was revised the next day in order to remove the fractured piece and the procedure was completed successfully with an unspecified surgical delay.
Event or Problem Description
It was reported that a portion of an es2 kwire broke off inside the patient intra-operatively.The patient was revised the next day in order to remove the fractured piece and the procedure was completed successfully with an unspecified surgical delay.
Additional Manufacturer Narrative
The date of explant has been provided, field d6b was subsequently updated.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 11784935
• Report Number: 0009617544-2021-00075
• Device Sequence Number: 11755217
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48280232
• Device Catalogue Number: 48280232
• Device Lot Number: B130692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/30/2021; 12/01/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/25/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown