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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
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
It was reported that a proximal targeting adapter did not target the second of two proximal holes.It was okay for the hole prior.The surgeon elected not to implant a second proximal screw.Operative side is left and there was approximately a 2 minute delay.
Event or Problem Description
It was reported that a proximal targeting adapter did not target the second of two proximal holes.It was okay for the hole prior.The surgeon elected not to implant a second proximal screw.Operative side is left and there was approximately a 2 minute delay.
Additional Manufacturer Narrative
D9 / h3 updated to indicate product was not available for return.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.A physical evaluation and review of the device history for the device in question was impossible as lot code was not provided and the physical device was not made available.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.

• 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; GM D-24232
• MDR Report Key: 11704191
• Report Number: 0009610622-2021-00448
• Device Sequence Number: 3460834
• Product Code: LXH
• UDI-Device Identifier: 04546540379719
• UDI-Public: 04546540379719
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 06/21/2021

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: 1806-3305
• Device Catalogue Number: 18063305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1