MAUDE Adverse Event Report: STRYKER GMBH 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49222020

Device Problem Positioning Problem (3009)

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

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the doctor was having problems with tightening the screws to tighten the lateral bars on the clamp.They cannot get the screw all the way through the hole, it seems like it is a specific area in the threaded hole.

Manufacturer Narrative

The reported incident that 5 hole pin clamp hoffmann 3 ø4/5/6mm was alleged of issue s-43 (assembling issue) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by overtightening.The functional inspection confirmed the failure mode: even if possible to tighten the screws for post holding, it is hard and this is not normal behaviour.During functional testing, it was shown that the screwing starts to get harder when the screw reach the second part of the threaded hole.No matter which side we put the screw in, the first half is always smooth but the second half is not.This means that screws and threads are correct but both threads are not aligned properly: this creates the difficulty to insert the screw.When the screw is reaching the second half and is engaged in both threads at the same time, force is needed to "re-align" both threads in order to allow the screw to continue its insertion.This misalignment can only be created by deformation of the device by overtightening the screw on this hole.Experience and complaints history showed that this overtightening is often done when disassembling and reassembling the device for cleaning and reprocessing.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.

Event Description

It was reported that the doctor was having problems with tightening the screws to tighten the lateral bars on the clamp.They cannot get the screw all the way through the hole, it seems like it is a specific area in the threaded hole.

• Brand Name: 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5508454
• MDR Text Key: 40845421
• Report Number: 0008031020-2016-00139
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K111786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49222020
• Device Lot Number: R36330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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): Required Intervention