MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251360S
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Devcie disposition is unknown.
Event or Problem Description
It was reported that the patient's left femur was revised due to a broken gamma nail, possible causes or contributors for implant breaking, including trauma, were not reported to the rep.The entire nail construct was revised to a hemi hip construct.As reported in medwatch report # 30020-2019-002: "patient with previous left intertrochantic femur fracture, status post cephalomedully nail placement on (b)(6) 2018.In (b)(6) 2019, patient experienced pain and x-rays showed showing failure of the proximal aspect of the left femur cephalomedullary nail.The nail had failed where the proximal interlocking screw for the femoral head and neck, knocking off the proximal aspect of the nail.Patient underwent removal of left hip femur hardware and a left hip hemiarthroplasty using restoration modular components".Report indicates the device is available for evaluation.
Additional Manufacturer Narrative
Correction: (lot#).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Patient is an 80-year-old female with a bmi of 28 (overweight), and as the implant broke after around 7 months of surgery, therefore a non-union is very likely, meaning the bone was not healed to the time of the nail breakage.The ifu includes that obesity, traumatic overloads and non-unions can lead to implant failures like breakages.Based on investigation, the root cause was attributed to patient related issue (non-union, high load, heavy weight) which led to the material damage.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient's left femur was revised due to a broken gamma nail, possible causes or contributors for implant breaking, including trauma, were not reported to the rep.The entire nail construct was revised to a hemi hip construct.As reported in medwatch report # 30020-2019-002: "patient with previous left intertrochantic femur fracture, status post cephalomedully nail placement on (b)(6) 2018.In january 2019 patient experienced pain and x-rays showed showing failure of the proximal aspect of the left femur cephalomedullary nail.The nail had failed where the proximal interlocking screw for the femoral head and neck, knocking off the proximal aspect of the nail.Patient underwent removal of left hip femur hardware and a left hip hemiarthroplasty using restoration modular components".Report indicates the device is available for evaluation.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM 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: 8401890
• Report Number: 0009610622-2019-00098
• Device Sequence Number: 253179
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 10/31/2022
• Device Catalogue Number: 35251360S
• Device Lot Number: K0A27AD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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 Age: 80 YR
• Patient Weight: 72