MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34200280S
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
At (b)(6) 2018, operation was done with long gamma nail.At (b)(6) 2018, suddenly she felt a pain when she was going down the hill.Therefore, she visited the hospital and confirmed breaking of the nail around the lag screw hole.At (b)(6) 2018, revision surgery is planned.After the proximal broken nail and lag screw were removed, extraction hook ((b)(4)) was hanged to the distal part of nail and hit with hammer and about 1mm of the tip of the extraction hook was lacked and the it was not able to be hanged to nail.Therefore, new hook was used, but the tip of the hook was bent after it was hit with hammer and not able to be used.Therefore, the distal part of the nail and broken hook was left in the patient body and operation was finished.Removal of nail remained in the patient's body was done.However, the distal part of the nail was not removed and it was left and chs implant (synthes) was deployed.Revision # 2 reported under separate pi.
Additional Manufacturer Narrative
The reported event of nail breakage could be confirmed.According to available information the gamma3 nail had broken after an implantation period of approx.8 months.General aspects: 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.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.In this case the item broke in a fatigue manner after an implantation period of approximately 8 months.From technical point of view the lateral edge of the anterior web had been damaged intra-operatively by deviation of the stepdrill ¿ causing chamfer-like material removal.This damage had weekend the material in such a way that tensile stresses had initiated an incipient crack.During usual load bearing the crack had progressed towards medial and separated finally in a residual fracture.A medical assessment was not possible due missing medical records.No indications of material, manufacturing or design related problems were found during the investigation.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated nail breakage was addressed adequately.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.Intra-operative damage, also pointed out in the labelling, was regarded being user related.Further, it could not be determined whether bone healing was sufficient after 6 months or more.With available information the event was not linked to a deficiency of the device.In case further information should become available, we reserve the right to update the investigation and change the root cause.
Event or Problem Description
At (b)(6) 2018, operation was done with long gamma nail.At (b)(6) 2018, suddenly she felt a pain when she was going down the hill.Therefore, she visited the hospital and confirmed breaking of the nail around the lag screw hole.At (b)(6) 2018, revision surgery is planned.After the proximal broken nail and lag screw were removed, extraction hook (18066160) was hanged to the distal part of nail and hit with hammer and about 1mm of the tip of the extraction hook was lacked and the it was not able to be hanged to nail.Therefore, new hook was used, but the tip of the hook was bent after it was hit with hammer and not able to be used.Therefore, the distal part of the nail and broken hook was left in the patient body and operation was finished.Removal of nail remained in the patient's body was done.However, the distal part of the nail was not removed and it was left and chs implant (synthes) was deployed.Revision # 2 reported under separate pi.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM 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
• MDR Report Key: 8081152
• Report Number: 0009610622-2018-01401
• Device Sequence Number: 14044308
• Product Code: HSB
• UDI-Device Identifier: 04546540375186
• UDI-Public: 04546540375186
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 11/30/2019
• Device Catalogue Number: 34200280S
• Device Lot Number: K04BE1C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 56