MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 35MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number 2030-6535-1

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Surgeon complained the two torx screws appeared to not be behaving as expected when using them.The screws reportedly were not progressing into the bone as the threads seemed to be affected.

Manufacturer Narrative

An event regarding thread damage involving an other hip screw was reported.The event was confirmed based on the device evaluation.Conclusions: it was reported that the bone screws were not advancing into the bone as expected and that the threads seemed to be affected.Evaluation of the returned device indicated that damage was observed on screw consistent with potential cross threading and attempted implantation and explantation.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Therefore event of screw damage was confirmed but root cause could not not be determined.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Surgeon complained the two torx screws appeared to not be behaving as expected when using them.The screws reportedly were not progressing into the bone as the threads seemed to be affected.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 35MM
• Type of Device: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7786467
• MDR Text Key: 117289974
• Report Number: 0002249697-2018-02548
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: 07613327037012
• Combination Product (y/n): N
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 2030-6535-1
• Device Lot Number: 782H6P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other