MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

The sales rep, reported on behalf of the customer, that all 4 click locks allegedly disengaged intra operatively when the surgeon was using a straight plate which the he had contoured to fit the patients' bone, upon introduction of the locking screw.The sales rep has reported that the customer had to intra operatively clamp the click locks into the plate to prevent intra operative dislocation of the click locks.The sales rep has advised that it was not reported if they are known to have disengaged post operatively.The sales rep has reported that he advised the customer about not bending the plates over a hole.The sales rep has commented that he still could not understand how holes not affected by bending would have issues with the click locks.The sales rep has forwarded the customer the op tech advice on bending which states that if the plate is used in a fully locked mode that bending is not recommended due to possible hole deformity and instability of locking insert placement, and that in a hybrid mode (compression with appropriate cortical screws and locking screws) the plate should only be bent above the fracture line between the compression holes.The sales rep has reported that the customer is concerned about the click lock disengagement.

Manufacturer Narrative

Evaluation summary: the reported event, no locking could not be confirmed.Based on the investigation, the root cause was attributed to a user related issue.The failure mode was caused by the bending of the plate (see notes below).The surgeon was using a straight plate which the he had contoured to fit the patients' bone.The sales rep has reported that he advised the customer about not bending the plates over a hole.If the plate is used in a fully locked mode, plate bending is not recommended due to possible hole deformity and inability of locking insert placement.If the plate is used in a hybrid mode (compression with appropriate cortical screws and locking screws.Intra-operative contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker osteosynthesis, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.Such action must be performed with stryker osteosynthesis instruments and in accordance with the specified procedures.The reported incident could not be confirmed, since the device was not returned for evaluation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4586320
• MDR Text Key: 5484440
• Report Number: 0008031020-2015-00091
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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