MAUDE Adverse Event Report: STRYKER GMBH LOCKING INSERT AXSOS 4.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number 370002

Device Problems Difficult To Position (1467); Connection Problem (2900)

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

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a proximal humerus fracture procedure the insert was not locking on the plate.Another another insert was used that locked properly.

Manufacturer Narrative

The reported event that a locking insert axsos 4.0mm locking set did not lock to a plate hole could be confirmed.Based on investigation, the root cause was attributed to be user related.These are some of the possible causes: - the plate was bent in the shaft region, below the oblong hole.This action is very well-known to affect the ability to place a locking insert.- the insert had already be used once.Single use devices cannot be reused, as they are not designed to perform as intended after the first usage.- the surgeon used wrong instruments or used the right instruments incorrectly.The device inspection revealed the following: the complained device did not present any visible breakage or crack.The most relevant dimensions (wings width and total length) were taken on both the returned device and an insert taken from stock (cat# 370002/lot# v38585).The ones of the device at issue resulted smaller than specifications.This comes as no surprise: the insert is a single use device, as, once inserted, its wings undergo plastic deformation in order to fit into a plate hole.The item taken from stock (thus never used) resulted according to specifications.The complained insert was attached to a locking insert inserter (cat# 702762) and attempted to be placed into a hole in the shaft portion of an axsos plate.The attempt was not successful.The insert did not lock to the plate.The same test was performed with the insert taken from stock.The device clicked and therefore locked to the plate.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 any further information is provided, the investigation report will be updated.The operative technique (axsos-st-20-en axsos proximal humerus op tech) was reviewed: '' plate contouring in the shaft region below the oblong hole is not recommended.Bending in this region may affect the ability to place a locking insert in a hole or to lock a screw in a threaded shaft hole.[.] pre-operative locking insert application if additional locking screws are chosen for the plate shaft, pre-operative insertion of locking inserts is recommended.A 4.0mm locking insert (ref 370002) is attached to the locking insert inserter (ref 702762) and placed into the chosen holes in the shaft portion of the plate [.].Ensure that the locking insert is properly placed.The inserter should then be removed [.].[.] intra-operative locking insert application if desired, a locking insert can be applied in a compression hole in the shaft of the plate intra-operatively by using the locking insert forceps (ref 702968), centering pin (ref 702673), adaptor for centering pin (ref 702675), and guide for centering pin (ref 702671).First, the centering pin is inserted through the chosen hole using the adaptor and guide.It is important to use the guide as this centers the core hole for locking screw insertion after the locking insert is applied.After inserting the centering pin bi-cortically, remove the adaptor and guide.Next, place a locking insert on the end of the forceps and slide the instrument over the centering pin down to the hole.Last, apply the locking insert by triggering the forceps handle.Push the button on the forceps once again to remove the device.At this time, remove the centering pin.'' [original statement(s)].The instruction for use (v15013 rev n non active implant ifu ot-ifu-105 rev 3) was reviewed: ''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 (e.G.Operative techniques).[.] single use devices cannot be reused, as they are not designed to perform as intended after the first usage.[.] pre-operative ¿ the implant is for single use only.'' [original statement(s)].

Event Description

During a proximal humerus fracture procedure the insert was not locking on the plate.Another another insert was used that locked properly.

• Brand Name: LOCKING INSERT AXSOS 4.0MM LOCKING SET
• 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: 5983811
• MDR Text Key: 56352077
• Report Number: 0008031020-2016-00476
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 370002
• Device Lot Number: R12889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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