MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X360MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3520-1360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/27/2020
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 fracture of the above medical device was noted by radiographic examination at 3 months post-operative.The patient was taken back for nail replacement.The cause of the fracture remains unexplained (no fall).A statement was sent to the (b)(6).
Additional Manufacturer Narrative
Due to the current covid-19 pandemic it was not possible to inspect the product as the access to the facility is restricted.The investigation will be reassessed as soon as restriction is lifted.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.As no item was returned no physical examination could be carried out.No non-conformity 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 indicates that such an 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.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
The customer reported that : "the fracture of the above medical device was noted by radiographic examination at 3 months post-operative.The patient was taken back for nail replacement.The cause of the fracture remains unexplained (no fall).A statement was sent to the ansm.
Additional Manufacturer Narrative
The reported event was confirmed.No medical records, i.E.X-rays, 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.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented the fracture pattern identified the nail broken in fatigue manner after an implantation period of approx.3 months.Intra-operative material damage had significantly weakened the material in highly stress applied area creating an incipient crack.Additional high axial load application by the patient had contributed to the event.Intra-operative material damage was regarded being user related.In case substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.
Event or Problem Description
The customer reported that : "the fracture of the above medical device was noted by radiographic examination at 3 months post-operative.The patient was taken back for nail replacement.The cause of the fracture remains unexplained (no fall).A statement was sent to the ansm.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X360MM X 120
• 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: 9751752
• Report Number: 0009610622-2020-00063
• Device Sequence Number: 14160599
• Product Code: HSB
• UDI-Device Identifier: 07613252274148
• UDI-Public: 07613252274148
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

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: 10/31/2022
• Device Model Number: 3520-1360S
• Device Catalogue Number: 35201360S
• Device Lot Number: K0948AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 08/26/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 05/27/2020; 09/22/2020
• 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
• Patient Age: 85 YR
• Patient Weight: 68