MAUDE Adverse Event Report: STRYKER GMBH CANN COMPRESSION SCREW 2.0X20MM, STST, STERILE; SCREW, FIXATION, BONE

Catalog Number 1415020

Device Problem Defective Component (2292)

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

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The biomedical engineer reported that the screw threads are defective.The surgeon at the hospital declared that during an hallux valgus surgery, when fitting the screw, damage to the distal thread happened, the screw threads were defective, same problem with another screw.It was also reported that the intervention ended well with no patient impact, no medical intervention, there was a surgical delay of 15 minutes with no adverse consequences.

Manufacturer Narrative

The reported event that cann compression screw 2.0x20mm, stst, sterile was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by high heat generation due to high mechanical force applied.The device inspection revealed that the screw is totally broken on the distal part.Generated debris show melted metal.Such a damage can only occur if the screw was inserted with too high speed and torque or if the screw came in contact with obstacle during insertion.Therefore this case is closed as user related.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

The biomedical engineer reported that the screw threads are defective.The surgeon at the hospital declared that during an hallux valgus surgery, when fitting the screw, damage to the distal thread happened, the screw threads were defective, same problem with another screw.It was also reported that the intervention ended well with no patient impact, no medical intervention, there was a surgical delay of 15 minutes with no adverse consequences.

• Brand Name: CANN COMPRESSION SCREW 2.0X20MM, STST, STERILE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6736531
• MDR Text Key: 81004443
• Report Number: 0008031020-2017-00445
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 1415020
• Device Lot Number: 78206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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