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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Upon opening the sterile packaging of gamma nail, a hair was found in the seal of the package.The rep was not in the case.

Manufacturer Narrative

Evaluation revealed the received trochanteric nail kit, ti gamma3® ø11x180mm x 125° (packaging) to be the primary product.Review of the dhr revealed no discrepancies, in particular in the packaging process.The reported event could not be reproduced as the packaging was received in opened condition (broken sealing).Pollution in original condition could not be verified.Upon receipt of the device the reported hair was found at the area of the originally sealed rim, fixed by a scotch tape, and should have been noticed prior to opening as it is visible through the clear blister.Due to adhesive power of the glued / sealed connection of tyvek - blister a white colored area remains on the blister when the tyvek® lid is torn off.This white area is called crazing resp.Stress whitening.A consistent white and not interrupted surface indicates that no sealed in foreign material (e.G.Hair) at the sealed area of the blister rim was present.In case of a sealed in hair a negative imprint would be apparent at the stress whitening.Furthermore, not enough information is available to confirm the reported case (like a photo of the unopened package).It could not be excluded that the pollution occurred at the user site.Based on the above observations the root cause could not be determined.No discrepancies were detected during risk analysis review.No nonconformity was identified.

Event Description

Upon opening the sterile packaging of gamma nail, a hair was found in the seal of the package.The rep was not in the case.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6867199
• MDR Text Key: 86613903
• Report Number: 0009610622-2017-00284
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 31251180S
• Device Lot Number: K0843BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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): Other