MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 33250400S

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that gamma nail broke.

Manufacturer Narrative

The evaluation revealed the broken gamma3 long nail to be the primary product.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 heavily drill marked within the anterior bridge of the proximal lag screw hole; a part of the bridge material is completely abraded at lateral.The anterior breakage line was found within the drill marked area.This misdrilling effect did weak the anterior bridge significantly and caused a notching effect on the lateral side that favours the nail breakage.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.Smooth lines of rest are visible on the anterior bridge breakage surface; the bridge broke step by step in a fatigue fracture.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 anterior bridge at lateral.After the anterior bridge was broken, the posterior bridge followed, first step by step (fatigue fracture) and finally in a spontaneous gliding fracture.Bearing points on the distal part of the proximal nail hole indicate that heavy loads were applied postoperatively to the implants; indicating that the implants were loaded by most likely full weight bearing.These loads also contribute to the nail breakage.The surgeon classified the fracture as high-grade instable per- to subtrochanteric fracture with multiple fragments.The operative technique addresses that instable fractures shall not be loaded with full weight; partial weight bearing walking is allowed for the first 6 to 8 weeks.Full weight bearing walking can be commenced when there is a bridging callus formed.The surgery reports and notes did not include any recommendation regarding weight bearing; it can¿t be excluded that the patient was not instructed correctly.Instable fractures, fractures with poor bone contact, 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.Because no manufacturer related issues were found the case is attributed to a deviation from the ifu and operative technique (user related), contributed by the patient.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.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM 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: 6105564
• MDR Text Key: 59994659
• Report Number: 0009610622-2016-00507
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153313564
• UDI-Public: 0107613153313564111506151720053110K046C0D
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 33250400S
• Device Lot Number: K046C0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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: 67 YR
• Patient Weight: 90