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

Model Number	1806-3302
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that while using the jig (target adapter) during a nailing case, the oblique locking screw - number 2 - missed the nail and ended up having a broken drill bit.The case was completed by taking out the broken drill and using the screw without the jig.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Several attempts were made but to no avail.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Finally, in case of any deviation this should be recognized during functional check, which is required per ifu but nothing was reported during pre-operative check performed.Thus, it could not be excluded that the case is rather related to a sub-optimal intraoperative procedure.Nevertheless, the implant[s] could be finally positioned in freehand, which is always an option and the surgery was completed successfully.No corrective actions are required at this time.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.H3 other text : device was not returned.
Event or Problem Description
The customer reported that while using the jig (target adapter) during a nailing case, the oblique locking screw - number 2 - missed the nail and ended up having a broken drill bit.The case was completed by taking out the broken drill and using the screw without the jig.

• Brand Name: 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; GM D-24232
• MDR Report Key: 11690024
• Report Number: 0009610622-2021-00444
• Device Sequence Number: 16918402
• Product Code: LXH
• UDI-Device Identifier: 04546540379689
• UDI-Public: 04546540379689
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/23/2021

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: 1806-3302
• Device Catalogue Number: 18063302
• Device Lot Number: KME193142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1