MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1008
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Femur target device 1806-1008 / 1806-1006, miss drilling.Strike plate 1806-0150 could not be screwed in replacement was available.Surgical delay of 30 min.Not longer.No other consequences reported.Additional information received from the op lead: the mis-drilling occurred at the proximal end.The issue was resolved by using second targeting arm and later ordered no patient impact, only 30 min op time increase.The threading of strike plate impacted in a way that it cannot be threaded into the targeting arm anymore.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Based on the fact that nothing was reported during pre-operative check, which is required per ifu, the root cause was attributed to a suboptimal intraoperative procedure and has to be classified as an user-customer-user error.Known from previous cases it could not be excluded that the user didn't tighten the fixation screw completely (allowing movement with the nail adapter) and heavy bending forces were applied [user related].Finally, referring to the long period since manufacturing [manufactured in 2012] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended.The device inspection revealed the following: visual inspection: the received items show traces of a long and intense use identified by the general appearance of the surface.The targeting arm shows signs of frequent usage as the general appearance of the white printings, which turned from white to fawn, is an indication for high sterilization cycles.The nail handle shows signs of frequent and intense use as well [marked with scratches and dents].Functional inspection: the returned devices were assembled.All nail holes of a sample nail were passed by a sample drill without nail contact; the reported misdrilling was not reproducible.Dimensional inspection: proper dimensions were confirmed by above mentioned functional check which revealed the relevant bores of the targeting arm being fully functional.Additionally, measure of dimensions was not applicable with regard to the nature of the reported event.The alleged guidance inaccuracy 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.No indications of material or design related problems were found during the investigation.
Event or Problem Description
Femur target device 1806-1008/1806-1006, miss drilling.Strike plate 1806-0150 could not be screwed in replacement was available.Surgical delay of 30min.Not longer.No other consequences reported.Additional information received from the op lead: the misdrilling occurred at the proximal end the issue was resolved by using second targeting arm and later ordered no patient impact, only 30min op time increase the threading of strike plate impacted in a way that it cannot be threaded into the targeting arm anymore.

• Brand Name: TARGETING ARM T2 FEMUR
• 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: 10653184
• Report Number: 0009610622-2020-00559
• Device Sequence Number: 16826293
• Product Code: LXH
• UDI-Device Identifier: 04546540196576
• UDI-Public: 04546540196576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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 Model Number: 1806-1008
• Device Catalogue Number: 18061008
• Device Lot Number: KME904449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1