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

Model Number	1806-2035
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/27/2020
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
As reported: "missdrilling occured during 3 medical procedures.".
Event or Problem Description
As reported: "missdrilling occured during 3 medical procedures.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: visual inspection: the targeting arm received showed traces of frequent and intense use.The original white printings have changed to fawn which is an indication for a high number of sterilization cycles.Functional inspection: a function test on the targeting arm (simulation of the pre-operative check that is required per our ifu was performed in order to reproduce the reported event.The test set up was completed with sample devices.The drill could be passed through the screw holes while checking all possible locking options.The alleged mistargeting could not be reproduced.Function is still given on the returned device ¿ proximally and distally.Dimensional inspection: proper dimensions were confirmed by above mentioned successful functional check which revealed the targeting arm being functional.Thus, additional measurements were deemed not necessary.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.Based on investigation, the root cause was attributed to a user related issue.The failure was rather caused by a sub-optimal intraoperative procedure and has to be classified as user-customer-user error.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10080253
• Report Number: 0009610622-2020-00256
• Device Sequence Number: 17124519
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: KHI127023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1