MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X380MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3520-1380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/11/2020
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 reported that the patient had been implanted with a gamma nail on (b)(6) 2020 and that the nail broke following a fall.Revision surgery will be required.
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.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 patient related.Although, it is evident that mis-drilling and signs of fatigue fracture were observed on the anterior web, but the breakage pattern on the posterior web suggests an abrupt breakage due to a high instantaneous load.This failure mode co-relates to the fact that the patient fell post-surgery, causing a sudden high impact on the devices, leading to their breakage (both nail and the locking screw exhibits abrupt breakage pattern).The breakage of nail was assisted by the mis-drilling but was predominantly caused due to the patient¿s fall.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The surgeon reported that the patient had been implanted with a gamma nail on (b)(6) 2020 and that the nail broke following a fall.Revision surgery will be required.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X380MM 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; DE D-24232
• MDR Report Key: 10123369
• Report Number: 0009610622-2020-00278
• Device Sequence Number: 2461843
• Product Code: HSB
• UDI-Device Identifier: 07613252274131
• UDI-Public: 07613252274131
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 06/30/2023
• Device Model Number: 3520-1380S
• Device Catalogue Number: 35201380S
• Device Lot Number: K05CFA8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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