MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	02/21/2020
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 gamma nail broke.X-ray image also showed broken locking screw.Revision surgery occurred as a result.
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.The fracture pattern resembles a fatigue fracture (evident by appearance of lines of rest/ waves).Starting from that region with an incipient crack at the lateral edge, the breakage progressed through the cross section.As a result of which the posterior web broke in a much quicker way with increased tensile load.Signs of which are visible along the curved edge of the posterior web.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.A clinical statement was requested for the evaluation of the provided medical data.Following statements are opined by him: ¿there is a subtrochanteric fracture treated with a long nail.Due to non-union at the fracture site it came to self mobilization (dynamization) of the proximal fragment with breakage and bending of the distal screws.However, this did not end up in healing but due to the ongoing non-union after a while the nail broke as well, although the initial reduction with the two cerclages did not look bad.Three reasons will have contributed to the outcome.Heavy load with the obese patient, the fracture pattern, which is always statically demanding and the misdrilling.¿ based on the above investigation, it is evident that the nail broke due to a combination of factors including a non-union, a complex fracture pattern, patient being obese and finally the mis-drilling but predominantly the root cause of the failure is patient related.Patient being obese had a great impact on the nail and eventually on the screw.The non-union also overloaded the nail and the screw.The nail was initially damaged during placement and hence also contributed to the failure.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that the gamma nail broke.X-ray image also showed broken locking screw.Revision surgery occurred as a result.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM 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: 9845752
• Report Number: 0009610622-2020-00114
• Device Sequence Number: 19565448
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 07/31/2023
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K0C0E2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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 Weight: 90