MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	08/05/2019
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
Broken gamma nail.Patient had pain and went to the hospital.Revision operation: (b)(6) 2019 - long gamma nail used.
Additional Manufacturer Narrative
The reported event could be confirmed.Device inspection revealed the following: the nail was received with a competitor device entangled with it, which as per the op-tech is an off-label use.It can be concluded the competitor device was used to extract the nail from the patient after it was broken.The received nail was completely broken in the web, with its superior part not available for evaluation.The evaluation of the broken surface of the inferior part revealed that the breakage originated from the posterior web.The smooth surface as well as partial visibility of lines of rest confirmed the breakage to be a fatigue fracture.Appearance of bearing marks on the inside of the posterior web suggests localization of lag screw load on the web due to external factors like additional stress on the nail.Starting from that region with an incipient crack the breakage progressed through the cross section.As a result of which the anterior web broke in a much quicker way with increased tensile load.The breakage started from the lateral side and chipped off from the medial side, as evident by abrupt ridges at the medial location (with regards to nail positioning).A clinical statement was requested for the evaluation of the provided medical data.Following statements are opined by him: ¿the x-rays show a subtrochanteric, reversed oblique type fracture.The reduction was assisted by a cerclage, but still is not optimal with a dislocation up to one centimeter.Nonunion occurred.Due to the missing union it came to a self-mobilization/compression of the nail-with the breakage of the screw further approximation of the fracture fragments occurred, but still no union resulted from this.¿ the question was presented of whether the patient¿s bones were osteoporotic/osteopenic or not, the reply was: ¿cannot be assessed with x-ray only.Over the age of 60-if the patient is female-this is not unlikely.¿ based on the above investigation and medical records, the root cause of the failure is patient-related.The failure occurred due to non-union of the bones.The reduction was done using a nail and a cerclage but was rather sub-optimal.As communicated by the customer, the patient¿s bones were osteoporotic which wasn¿t denied by the medical expert as well.The patient¿s details also revealed that the patient was obese, and obesity significantly reduces the bone healing process.Thus, all these reasons altogether led to the non-union.Under a condition of non-union, all the load around the region starts acting on the implant, hence the implants break (fatigue fracture) under this increased load over a period of time.In this case the nail broke first and consequently under immensely increased load the distal screw broke.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.The instruction for use was reviewed suggests to the user that: ¿ obesity.An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
Broken gamma nail.Patient had pain and went to the hospital.Revision operation: (b)(6) 2019 - long gamma nail used.

• Brand Name: LONG NAIL KIT R1.5, 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
• MDR Report Key: 9158520
• Report Number: 0009610622-2019-00812
• Device Sequence Number: 11308033
• Product Code: HSB
• UDI-Device Identifier: 07613252274292
• UDI-Public: 07613252274292
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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 Catalogue Number: 35251380S
• Device Lot Number: K0C0E22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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: 75