MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L28MM; PLATE, FIXATION, BONE

Catalog Number 371528S

Device Problem Difficult to Insert (1316)

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

Event Date 01/24/2016

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

The customer, reported that when the surgeon,tried to put 4mm locking screws into the distal hole in the plate the head wouldn't go through the hole.A very small part of the head came off one of the screws.It was not reported whether this fell into the surgical site but the customer has the small fragment set aside.The surgeon removed the 4mm screws and replaced them with 3.5mm locking screws which did go through the axsos distal lateral tibial plate.The sales representative reported that the surgeon did not reverse the 4mm screws first to centralize them ie he omitted the back turn recommended in the ifu.There was a 10 minute delay to surgery the sales representative reported on behalf of the customer that unsuccessful attempts were made to insert three 4mm screws.

Manufacturer Narrative

The reported incident that one locking screw axsos 4.0mm / l75mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Moreover, since the patient record labels of 8 axsos 4.0mm locking screws were provided but it was not specified which of the screws is the one which broke, all the 8 screws have been investigated for sake of safety and completeness.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by incorrect surgical procedure.Indeed, as reported by the sales representative, the surgeon did not reverse the axsos 4.0mm locking screws a few turns in order to adjust screw alignment when necessary, thus leading to screw head breakage.Please note that the operative technique (axsos-st-3 en rev 2 axsos proximal lateral tibia optech) states the following: ''if power insertion is selected after manual start (see above), use low speed only, do not apply axial pressure, and never ¿push¿ the screw through the plate! allow the single, continuous threaded screw design to engage the plate and cut the thread in the bone on its own, as designed.Stop power insertion approximately 1cm before engaging the screw head in the plate.Power can negatively affect screw insertion, if used improperly, damaging the screw/plate interface (screw jamming).This can lead to screw heads breaking or being stripped.Again, if the locking screw does not advance, reverse the screw a few turns, and realign it before you start reinsertion.'' furthermore, the instruction for use (v15013 rev m non active implant ifu ot-ifu-105 rev 2) was reviewed and the following applicable warnings were identified: ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.For your information, avail yourself of the training courses and publications offered.Intra-operative: avoid surface damage of implants.'' a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The customer, reported that when the surgeon,tried to put 4mm locking screws into the distal hole in the plate the head wouldn't go through the hole.A very small part of the head came off one of the screws.It was not reported whether this fell into the surgical site but the customer has the small fragment set aside.The surgeon removed the 4mm screws and replaced them with 3.5mm locking screws which did go through the axsos distal lateral tibial plate.The sales representative reported that the surgeon did not reverse the 4mm screws first to centralize them ie he omitted the back turn recommended in the ifu.There was a 10 minute delay to surgery.The sales representative reported on behalf of the customer that unsuccessful attempts were made to insert three 4mm screws.

• Brand Name: LOCKING SCREW AXSOS 4.0MM / L28MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5450803
• MDR Text Key: 38727203
• Report Number: 0008031020-2016-00069
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 371528S
• Device Lot Number: J15720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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