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

Model Number	1806-3305
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/20/2020
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
The customer reported that the aiming jig for short length supracondylar nails is inaccurate and as a consequence missing the nail.
Additional Manufacturer Narrative
Correction: refer to d10/d3 device availability.The reported event that proximal target adapter t2 scn was alleged of instrument - misdrilling could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Due to unknown lot code a dhr review was impossible.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.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 : device disposition is unknown.
Event or Problem Description
The customer reported that the aiming jig for short length supracondylar nails is inaccurate and as a consequence missing the nail.

• 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; DE D-24232
• MDR Report Key: 9963928
• Report Number: 0009610622-2020-00150
• Device Sequence Number: 11399562
• Product Code: LXH
• UDI-Device Identifier: 04546540379719
• UDI-Public: 04546540379719
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 07/09/2020

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: 1806-3305
• Device Catalogue Number: 18063305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1