MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 17965040S

Device Problems Difficult to Insert (1316); Defective Component (2292); Torn Material (3024)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

It was reported by the (b)(4) : "during the implantation of a gamma nail, impossible to screw the distal screw into the nail.Screw thread defective, torn screw.Nail implanted without this distal screw, surgeon did not want to replace it.".

Manufacturer Narrative

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

Manufacturer Narrative

The locking screw was classified as primary product by the event description.No deviations were found during review of the manufacturing and inspection documents (dhr).The screw was documented as faultless prior to distribution.An inspection of the screw was not possible because it was not available, furthermore no x-rays or surgery reports were provided; the root cause of the issue could not be determined.It is likely that the screw hit the distal nail hole rim during insertion; due to the contact the thread got flattened and damaged (¿torn¿).In case the user used a target device maybe too much bending force was brought onto the device during drilling / insertion or the target device was defect.The operative technique explains that every instrument must be checked prior to every surgery in a pre-operative check.Based on the given information and the fact that no fault was found in the dhr a manufacturing issue can be excluded.No non-conformity identified.

Event Description

It was reported by the (b)(6): "during the implantation of a gamma nail, impossible to screw the distal screw into the nail.Screw thread defective, torn screw.Nail implanted without this distal screw, surgeon did not want to replace it.".

• Brand Name: LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4331342
• MDR Text Key: 5143470
• Report Number: 0009610622-2014-00689
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 17965040S
• Device Lot Number: K087C5D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other