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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Primary procedure, right femur.It was reported that in using a cannulated lag screw step drill with guide wire, the drill bit broke off in patient's bone.Surgeon was able to remove the piece and verify removal by use of c-arm.A surgical delay of approximately 20 minutes was reported.Patient's bone quality was not reported to the rep.
Additional Manufacturer Narrative
The reported event that stepdrill for lag screw t2 recon was alleged of issue k-275-c (instruments - step drill - broken) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Stryker devices are inspected before being released for distribution, if any deviation would have been noticed, a nonconformance would have been raised.This is the first reported case with this lot number, the device can be therefore confirmed faultless prior the distribution.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.The ifu and operative technique includes in detail that the instruments shall be checked prior to every surgery and how the instruments shall be sued correctly.A review of the labeling did not indicate any abnormalities.Device disposition is unknown.
Event or Problem Description
Primary procedure, right femur.It was reported that in using a cannulated lag screw step drill with guide wire, the drill bit broke off in patient's bone.Surgeon was able to remove the piece and verify removal by use of c-arm.A surgical delay of approximately 20 minutes was reported.Patient's bone quality was not reported to the rep.

• 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; postfach; schoenkirchen/kiel D-242 32
• MDR Report Key: 7636389
• Report Number: 0009610622-2018-00246
• Device Sequence Number: 11237658
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 11/29/2018

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: Health Professional
• Device Catalogue Number: 18063025
• Device Lot Number: KU93566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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: 71 YR