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

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

On (b)(6) 2018: 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.Rev # 2.

Event Description

On (b)(6) 2018: 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.Rev # 2.

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.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 labeling.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 step drill ¿ 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 nonconformity was identified.Intra-operative damage, also pointed out in the labeling, 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.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 120°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8081334
• MDR Text Key: 127536193
• Report Number: 0009610622-2018-01406
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375186
• UDI-Public: 04546540375186
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 34200280S
• Device Lot Number: K04BE1C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 56