MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL TARGET ADAPTER T2 SCN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18063305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that when the distal side of the proximal screw was inserted, it missed the target.Therefore, the screw was removed and operation was finished.The doctor's comment: when drilling for the proximal lateral screw, sometimes involved fascia, it may be due to a failure to drill smoothly.
Additional Manufacturer Narrative
The reported event that proximal target adapter t2 scn was alleged of - proximal misdrilling / problems during drilling could not be confirmed, since the returned device is conforming to specifications and fully functional.Based on investigation, the root cause was attributed to a user related issue.The failure is rather related to a sub-optimal intraoperative procedure.The device inspection revealed the following: the received proximal target adapter t2 scn shows traces of a long and intense use.The printings on the target device were turned from white to fawn; an indication for a high level of sterilization cycles.Apart from that, the device is in general good condition and further significant damage was not found.A pre-surgical function test (¿pre-operative check¿) with the returned proximal target adapter and sample devices was performed.The function of the target adapter was still given.The alleged mis-targeting could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
It was reported that when the distal side of the proximal screw was inserted, it was missed the target.Therefore, the screw was removed and operation was finished.The doctor's comment: when drilling for the proximal lateral screw, sometimes involved fascia, it may be due to a failure to drill smoothly.

• Brand Name: PROXIMAL TARGET ADAPTER T2 SCN
• 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: 8061877
• Report Number: 0009610622-2018-01380
• Device Sequence Number: 1439601
• Product Code: LXH
• UDI-Device Identifier: 04546540379719
• UDI-Public: 04546540379719
• 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): 02/14/2019

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: 18063305
• Device Lot Number: KME904148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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: Other
• Patient Age: 82 YR