MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON 12X380 MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1843-1238S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/20/2021
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 the patient had a l subtrochanteric hip fracture fixed with a 12x380mm reconstruction nail on (b)(6) 2020.Patient went on to nonunion and a broken implant on (b)(6) 2021.The implant broke at the level of the inferior recon screw.Nail was removed on (b)(6) 2021 and revised with a smith and nephew intertan.
Event or Problem Description
It was reported the patient had a l subtrochanteric hip fracture fixed with a 12x380mm reconstruction nail on (b)(6) 2020.Patient went on to nonunion and a broken implant on (b)(6) 2021.The implant broke at the level of the inferior recon screw.Nail was removed on (b)(6) 2021 and revised with a smith and nephew intertan.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken from one of the proximal holes.Significant drill marks were found at the lateral entrance of the hole; they progress through the bore towards medial.The drill marks were generated by a deviated drill which most likely had created the starting point of the fracture (notching effect) somewhere at the lateral edge.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves and partial shiny surface.Also, one of the edges of the distal round hole shows signs of intra-operative misdrilling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought from an independent medical professional for the provided x-rays.Strictly based on the available information he opined that the breakage is most likely due to a non-union.The fracture has an atypical location and morphology and is pretty likely associated to bisphosphonate intake.Also, it would have been advisable to select dynamic locking for the given fracture type to achieve necessary compression.Overall, there is a strong patient related factor with the location and highly unstable fracture pattern along with a user related attribution to the failure by not going with a dynamic locking, thus preventing compression at the fracture site.Based on the above investigation, the root cause of the issue is related to a combination of both user and patient related factors, but predominantly it is patient related.If any further information is provided, the complaint report will be updated.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON 12X380 MM 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: 11967449
• Report Number: 0009610622-2021-00547
• Device Sequence Number: 11106223
• Product Code: HSB
• UDI-Device Identifier: 04546540412294
• UDI-Public: 04546540412294
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 04/30/2024
• Device Model Number: 1843-1238S
• Device Catalogue Number: 18431238S
• Device Lot Number: K06FE47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 54