MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251200S

Device Problems Break (1069); Crack (1135)

Patient Problem Pain (1994)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A breakage of the implant at high of the femoral head screw was reported.Patient feeled a crack during walking femoaral left side, increasing pain, contact to surgeon at (b)(6) 2017.

Manufacturer Narrative

The evaluation revealed the broken gamma3 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, dimensional or manufacturing related issues were found.The breakage surfaces of both bridges show lines of rest, spreading from lateral towards medial; indicating a fatigue fracture.The anterior bridge is drill-damaged at lateral; the breakage started at this point, so the anterior bridge broke prior to the posterior bridge.Rough and cliffy structures at medial indicate that after the main part of the nail broke step by step both bridges broke spontaneous in a forced gliding rest fracture.The provided patient data, mobilization and implantation time show no abnormalities.Based on the given data the nail broke due to the drill-damage at lateral of the nail (user related).The operative technique and ifu include that special care must be taken during pre-drilling of the lag screw to avoid implant damages.If other listed adverse effects, like poor bone healing, diseases, etc.Did contribute to the nail breakage could not be determined due to missing information.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

A breakage of the implant at high of the femoral head screw was reported.Patient feeled a crack during walking femoaral left side, increasing pain, contact to surgeon at (b)(6) 2017.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: 6423076
• MDR Text Key: 70522168
• Report Number: 0009610622-2017-00082
• Device Sequence Number: 1
• Product Code: HSB
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 31251200S
• Device Lot Number: K0DF425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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: 75 YR
• Patient Weight: 69