MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STEPDRILL FOR LAG SCREW T2 RECON; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18063025
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Breakage of the cephalic reamer during reaming of the femoral neck.The surgeon made section on the spot to recover the piece.Surgical delay: 90 min.
Event or Problem Description
Breakage of the cephalic reamer during reaming of the femoral neck.The surgeon made section on the spot to recover the piece.Surgical delay: 90 min.
Additional Manufacturer Narrative
The reported event that stepdrill for lag screw t2 recon was broken could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received step drill shows intense traces of use and the distal portion (tip) of the drill is also sheared off.Based on the investigation, massive bending forces during drilling at the outer surface of the nail may have led to the breakage of the tip of the drill.The exact root cause of the reported event could not be determined but the appearance and extent of damage indicates that the root cause of the reported event is not linked to a deficiency of the device but is rather related to user error.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: STEPDRILL FOR LAG SCREW T2 RECON
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8337606
• Report Number: 0009610622-2019-00068
• Device Sequence Number: 1739949
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 18063025
• Device Lot Number: KU93568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 65