MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that gamma nail broke.The customer reported the case to the bfarm; the bfarm provided the report to stryker on (b)(6) 2016.In the initial report provided by the customer it is stated that the fracture is a pertrochanteric femur fracture.The patient was fallen after approx.7 months ((b)(6) 2016) after implantation and the nail broke.

Manufacturer Narrative

The broken gamma3 trochanteric nail was classified as primary product during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail returned was documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The nail was found heavily drill marked at the posterior bridge within the proximal lag screw hole.The breakage line was found within the drill marked area.This misdrilling effect caused by the lag screw step drill did weak the posterior bridge significantly and caused a notching effect on the lateral side that favours the nail breakage.Lines of rest are visible on the bridge breakage surfaces; the bridges broke step by step.The lines of rest run from lateral towards medial.These lines of rest indicate (in combination with the found drill marks), that the nail breakage started at the posterior bridge at lateral.After the posterior bridge was full or main partly broken, the anterior bridge followed also step by step but quicker than the posterior bridge.The nail broke due to a fatigue fracture.Bearing points within the proximal nail hole indicate that loads were applied postoperatively to the implants over a long period; these loads did most likely also contribute to the nail breakage.The customer reported that the patient was fallen four weeks before the hospital follow up visit.Most likely the nail and bone got fractured due to a traumatic overload.Traumatic overloads, postoperatively loads and intra-operatively implant damages are adverse effects that can lead to implant breakages and are listed in the ifu and operative technique.Misdrilling could occur in case the target device was pre-damaged, instruments were not assembled correctly or bending forces were applied to the drill and/or target device during drilling.The operative technique includes that the target device shall be checked prior to every surgery.Because no manufacturer related issues were found the case is attributed to the patient, contributed by the user.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

It was reported that gamma nail broke.The customer reported the case to the bfarm; the bfarm provided the report to stryker on (b)(6) 2016.In the initial report provided by the customer it is stated that the fracture is a pertrochanteric femur fracture.The patient was fallen after approx.7 months ((b)(6) 2016) after implantation and the nail broke.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6181128
• MDR Text Key: 62597554
• Report Number: 0009610622-2016-00629
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 31251180S
• Device Lot Number: K099D1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR