MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 40MM; SCREW, FIXATION, BONE

Catalog Number 2030-6540-1

Device Problems Difficult to Insert (1316); Material Separation (1562); Metal Shedding Debris (1804); Physical Resistance (2578); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that during the insertion of an acetabular bone screw, which was drilled for using the appropriate drill bit, drill guide and measured for using a depth gauge, the 40mm screw was advanced into the prepared drill hole to an approximate depth of 3/4's of the screws length.At this depth the surgeon began to feel screw path resistance.He proceeded to back the screw out of its pilot hole for re-insertion.The second try produced the same resistance at approximately the same depth of screw insertion as the first attempt.When backing out the screw for the second time, a small piece metal debris became visible at the screw/bone interface.Both the screw and small piece of metal debris were removed from the surgical field and put aside.A secondary, new 40mm screw was then opened and again advanced into the same pilot hole that was previously prepared.Again, screw path resistance was felt at the approximate screw depth as the first screw.The second screw was removed, with similar damage visible to the screw threads at the proximal portion of the screw.The second damaged screw was removed and set aside along with the first damaged screw.At this time, the surgeon prepared a different pilot hole using the appropriate drill bit, drill guide and depth gauge.A third 40mm screw was opened and successful inserted into the new pilot hole without resistance or screw damage.

Manufacturer Narrative

An event regarding damaged threads involving a 6.5 cancellous bone screw was reported.The event was confirmed.Method & results: device evaluation and results: the damage was examined by the material analysis team who indicated the damage was consistent with insertion of the screw in an off-axis manner resulting in contact with the shell at the through-hole site.This contact is consistent with the rotation of the bone screw during insertion resulting in the crest portion of the threads being sheared off through the overload failure.Medical records received and evaluation: no medical records or x-rays were made available for evaluation device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that the damage was consistent with the reported manner in which the screw was inserted, allowing it to contact the trident cup and shear off the crest of the threads.

Event Description

It was reported that during the insertion of an acetabular bone screw, which was drilled for using the appropriate drill bit, drill guide and measured for using a depth gauge, the 40mm screw was advanced into the prepared drill hole to an approximate depth of 3/4's of the screws length.At this depth the surgeon began to feel screw path resistance.He proceeded to back the screw out of its pilot hole for re-insertion.The second try produced the same resistance at approximately the same depth of screw insertion as the first attempt.When backing out the screw for the second time, a small piece metal debris became visible at the screw/bone interface.Both the screw and small piece of metal debris were removed from the surgical field and put aside.A secondary, new 40mm screw was then opened and again advanced into the same pilot hole that was previously prepared.Again, screw path resistance was felt at the approximate screw depth as the first screw.The second screw was removed, with similar damage visible to the screw threads at the proximal portion of the screw.The second damaged screw was removed and set aside along with the first damaged screw.At this time, the surgeon prepared a different pilot hole using the appropriate drill bit, drill guide and depth gauge.A third 40mm screw was opened and successful inserted into the new pilot hole without resistance or screw damage.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 40MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5230707
• MDR Text Key: 31656269
• Report Number: 0002249697-2015-03793
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: 905WXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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): Other