MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1340S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/05/2020
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
As reported, gamma 3 nail broke through the lag screw hole on the (b)(6) 2020.The nail was removed on the (b)(6) 2020 and a synthes blade plate inserted.Surgeon thought the time from implantation until failure fairly short.He said the original fracture was a very challenging type but it had been reduced well and the nail appeared to be implanted all in accordance with the surgical technique.The original operation was performed at (b)(6) hospital.
Event or Problem Description
As reported, gamma 3 nail broke through the lag screw hole on the (b)(6) 2020.The nail was removed on (b)(6) 2020 and a synthes blade plate inserted.Surgeon thought the time from implantation until failure fairly short.He said the original fracture was a very challenging type but it had been reduced well and the nail appeared to be implanted all in accordance with the surgical technique.The original operation was performed at (b)(6).
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, left gamma3® ø11x340mm x 125° was alleged of issue ¿implant - breakage post-operative¿ could be confirmed, although the device was not returned for evaluation but a x-ray was shared through which we can confirm the event.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.Due to the current covid-19 pandemic, it was not possible to receive the product for evaluation.The investigation will be reassessed as soon as the product is received.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 ifu instructs users that: ¿in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.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, osteomalacia, 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.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on the past complaint history and risk management the most probable root cause would be but not limited to; patient factor (non-union), poor bone formation and increased loading associated with delayed unions and/or non-unions.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported, gamma 3 nail broke through the lag screw hole on the (b)(6) 2020.The nail was removed on the (b)(6) 2020 and a synthes blade plate inserted.Surgeon thought the time from implantation until failure fairly short.He said the original fracture was a very challenging type but it had been reduced well and the nail appeared to be implanted all in accordance with the surgical technique.The original operation was performed at (b)(6) hospital.
Additional Manufacturer Narrative
Correction: sections d (device availability), h3, h6 (patient code).The reported event was confirmed.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nonconformity/corrective action had been filed for the item in question.Potential implant breakage had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling also points out potential reasons for insufficient bone healing ¿ e.G.But not limited to osteoporosis and / or diabetes and points out that an intra-operatively damaged implant is at risk for breakage.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented the fracture pattern identified the nail had broken in fatigue manner after an implantation period of approx.2 months.Intra-operative material damage had significantly weakened the material in highly stress applied area creating an incipient crack.Static locking of the lag screw had prevented intended subsidence of the bone fragments.Additional high axial load application by the patient had contributed to the event.Intra-operative material damage and statically locked lag screw were regarded being user related.In case substantive information becomes available we reserve the right to re-open the investigation with root cause assessment.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM 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: 9928477
• Report Number: 0009610622-2020-00140
• Device Sequence Number: 14157607
• Product Code: HSB
• UDI-Device Identifier: 07613252274278
• UDI-Public: 07613252274278
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 08/05/2020

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: 05/31/2023
• Device Model Number: 3525-1340S
• Device Catalogue Number: 35251340S
• Device Lot Number: K036EB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 07/09/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/02/2020; 08/05/2020
• 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