MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X280MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0280S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that after surgery, the nail broke; revision surgery was performed as a result.It was also reported that the revision surgery took a lot of time, but no specific amount was given.
Event or Problem Description
It was reported that after surgery, the nail broke; revision surgery was performed as a result.It was also reported that the revision surgery took a lot of time, but no specific amount was given.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not available for return.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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 review of the device history and corresponding labeling for the device in question was impossible due to unknown lot code.No corrective actions are required at this time.An indication of material, manufacturing or design related problems could not be checked as the device was not made available for a physical evaluation.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future that suggests otherwise we reserve the right to review and reopen the case.H3 other text : device disposition is unknown.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X280MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11942710
• Report Number: 0009610622-2021-00536
• Device Sequence Number: 19970459
• Product Code: HSB
• UDI-Device Identifier: 04546540375704
• UDI-Public: 04546540375704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3525-0280S
• Device Catalogue Number: 35250280S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention