MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2020
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 surgeon has informed the sales rep by phone about a broken gamma nail.Additionally reported: the gamma nail broke at the through-hole for the femoral neck screw.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.In this breakage remarkable to note was the two modes of fracture.The fracture pattern on the anterior web resembles a fatigue fracture (evident by appearance of lines of rest/ waves).Starting from that region with an incipient crack due to material erosion at the lateral edge, the breakage progressed through the cross section.This just weakened the nail.But with the fracture pattern in the posterior web, it suggests that after a while the breakage was abrupt and instantaneous with material chip off from the side.Severe drill marks were found at the lateral entrance of the proximal through hole at the anterior web; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the anterior web.Based on the provided medical records, the medical opinion was sought from an experienced independent medical expert which revealed the following; ¿the use of a long nail in this complex more subtrochanteric multi-fragment fracture with a long medial split fragment is highly likely to end up in a non-union.Yes, it is clear that the breakage of the nail can only occur with a delayed or non-union.Otherwise the load would have been overtaken by the bone and the nail would have become more or less inactive.Non-union due to insufficient bone healing.It could have been supported by additional measurements.¿ 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.Based on the above investigation, the root cause of the failure is user related.In medial neck fractures, the usage of long nail is a contradiction as also stated by the optech.It is also supported by the medical expert¿s opinion ¿the use of a long nail in this complex more subtrochanteric multi-fragment fracture with a long medial split fragment is highly likely to end up in a non-union.¿ he also said ¿it is clear that the breakage of the nail can only occur with a delayed or non-union.Otherwise the load would have been overtaken by the bone and the nail would have become more or less inactive.¿ apart from this, even signs of mis-drilling and fatigue fracture were observed on the anterior web and the breakage pattern on the posterior web suggests an abrupt breakage due to a high instantaneous load.The breakage of nail was assisted by the mis-drilling.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The surgeon has informed the sales rep by phone about a broken gamma nail.Additionally reported: the gamma nail broke at the through-hole for the femoral neck screw.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X360MM 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; DE D-24232
• MDR Report Key: 10176436
• Report Number: 0009610622-2020-00296
• Device Sequence Number: 19489316
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 01/31/2024
• Device Model Number: 3525-1360S
• Device Catalogue Number: 35251360S
• Device Lot Number: K08B1C4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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