MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X360MM X 130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3430-1360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
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 gamma nail which had been implanted on 7th january failed.
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - device was not returned.The reported event was not confirmed.Since the device was not returned for evaluation and no other evidences were provided.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential implant breakage had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling also points out potential reasons for insufficient bone healing ¿ e.G.But not limited to osteoporosis and / or diabetes and points out that an intra-operatively damaged implant is at risk for breakage.The labelling points out that product damage must be avoided.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a gamma3 long nail had allegedly broken after an implantation period of allegedly 3 months.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.With available information a deficiency of the device could not be verified.A root cause could not be determined.
Event or Problem Description
The customer reported that the gamma nail which had been implanted on (b)(6) failed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X360MM X 130
• 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: 11807109
• Report Number: 0009610622-2021-00511
• Device Sequence Number: 17058635
• Product Code: HSB
• UDI-Device Identifier: 07613252273981
• UDI-Public: 07613252273981
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Expiration Date: 05/31/2025
• Device Model Number: 3430-1360S
• Device Catalogue Number: 34301360S
• Device Lot Number: K0C7153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: Other