MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL-TIP RECON K-WIRE IMN INSTRUMENTS 3.2X400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-3240S
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "surgeon was implanting a t2 alpha femoral nail-gt (2333-1240s) utilizing the recon screws.While inserting the drill tip guide wire (2351-3240s), it missed the nail.After attempting to re-insert the guide wire, the tip broke off inside the patient.The surgeon was unable to retrieve the broken piece, and it remained inside the patient.About 5-8mm broken piece left inside the patient.Surgeon did not insert recon screws.Instead implanted two 5.0mm locking screws proximally.".
Event or Problem Description
As reported: "surgeon was implanting a t2 alpha femoral nail-gt (2333-1240s) utilizing the recon screws.While inserting the drill tip guide wire (2351-3240s), it missed the nail.After attempting to re-insert the guide wire, the tip broke off inside the patient.The surgeon was unable to retrieve the broken piece, and it remained inside the patient.About 5-8mm broken piece left inside the patient.Surgeon did not insert recon screws.Instead implanted two 5.0mm locking screws proximally.".
Additional Manufacturer Narrative
The reported event was not confirmed.The device was not received for investigation because discarded resp.Implanted.The dhr was reviewed.No suspicious situation determined.A review of the nc database revealed no nc for the product in question with this failure mode.The labelling requires check with image intensifier while inserting the k-wire.The risk management file review revealed no conspicuities.More information as well as the device must be returned to determine the exact root cause.With available information and without product a root cause could not be determined.In case essential information becomes available we reserve the right to re-open and to up-date the investigation results.

• Brand Name: DRILL-TIP RECON K-WIRE IMN INSTRUMENTS 3.2X400MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11250915
• Report Number: 0009610622-2021-00254
• Device Sequence Number: 11645985
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: 07613327361698
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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 Expiration Date: 08/31/2023
• Device Model Number: 2351-3240S
• Device Catalogue Number: 23513240S
• Device Lot Number: K02E09D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR