MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREW, T7, 2.7X14MM; PLATE, FIXATION, BONE

Catalog Number 53-27614S

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 03/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the heads came off two (2.7 x 14mm) locking screws for the variax distal radius system when implanted into a plate.The threaded part of the screws were unretrievable and so left in situ.The heads were retrieved from the patient.The surgeon had used the 1.9 drill bit.The surgeon also reported to the stryker sales rep, that there were sufficient screws to hold the plate in place.The patient was young with tough bone.

Manufacturer Narrative

The reported event that a locking screw, t7, 2.7x14mm was alleged of breakage during surgery could be confirmed thanks to the provided post-operative x-rays.Based on investigation, the root cause was attributed to be user related.The failure was mainly caused by the fact that neither 2.7 mm tap (62-27010) nor 2.3 mm cortical drill bit (60-23141, 60-23341, 60-23441) were used during screw insertion in cortical hard bone.Both our operative technique and ifu clearly state that, in this kind of situation, it is recommended to use one of these devices to insert the 2.7mm screw in order to reduce the risk of screw breakage during insertion.Moreover, the following factors may have contributed to the occurrence of the reported event: too high forces were applied during screw insertion.Our ifu explain that screws should not be over-tightened during insertion.Excessive overtightening compromises the integrity of the screw head, thus resulting in possible screw breakage.When engaging the screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head.This results in proper axial alignment and full contact between driver and screw, minimizing the risk of damage and leading to optimal friction fit performance.The screw was not handled/stored carefully and its integrity was not verified prior to surgery.Scratching or damage to the implants can significantly reduce the strength and fatigue resistance of the product.Our ifu explain that all implants should be verified for proper function prior to each clinical use.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 the heads came off two (2.7 x 14mm) locking screws for the variax distal radius system when implanted into a plate.The threaded part of the screws were unretrievable and so left in situ.The heads were retrieved from the patient.The surgeon had used the 1.9 drill bit.The surgeon also reported to the stryker sales rep, that there were sufficient screws to hold the plate in place.The patient was young with tough bone.

• Brand Name: LOCKING SCREW, T7, 2.7X14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6446975
• MDR Text Key: 71502482
• Report Number: 0008010177-2017-00070
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K080667
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Catalogue Number: 53-27614S
• Device Lot Number: 1000210047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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
• Patient Age: 36 YR