MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT T20, AO FITTING; SCREW, FIXATION, BONE

Catalog Number 703540

Device Problems Break (1069); Fracture (1260)

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

Event Date 03/09/2015

Event Type  malfunction  

Event Description

During sales rep training, the sales rep fixed the distal femoral plate by the locking screw using torque limiter.Afterwards, the sales rep tried to remove screw using the screw driver.The tip of the screw driver broke.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event of the screwdriver breakage could be confirmed, since the returned device matched the reported failure.Based on the investigation, the root cause was attributed to a r&d/design related issue.The breakage was caused by the application of excessive torsional force on the device.The visual inspection revealed that the fracture pattern is consistent with the application of a high torsional force on the screwdriver.This issue was addressed by the nc.A design change was implemented, so as to increase the resistance of the screwdriver to torque forces by shortening the length of the blade of the device.The reported device was manufactured according to an old drawing, where this change had not been implemented yet.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 or manufacturing related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

During sales rep training, the sales rep fixed the distal femoral plate by the locking screw using torque limiter.Afterwards, the sales rep tried to remove screw using the screw driver.The tip of the screw driver broke.

• Brand Name: SCREWDRIVER BIT T20, AO FITTING
• Type of Device: SCREW, 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: 4651940
• MDR Text Key: 5598326
• Report Number: 0008031020-2015-00124
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 703540
• Device Lot Number: K843948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other