MAUDE Adverse Event Report: SYNTHES GMBH CANNSCR Ø3.5 SELF-DRILL L48/15 SST; SCREW, FIXATION, BONE

Catalog Number 205.148

Device Problems Material Twisted/Bent (2981); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.It is unknown when the screw bent as it was discovered during investigation of the returned device.Device is not distributed in the united states, but is similar to device marketed in the usa.Part 205.148, lot 48p9450: manufacturing site: (b)(4).Release to warehouse date: march 27, 2020.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.A product investigation was completed: visual analysis of the returned sample revealed that the screw was bent at the shaft.No other problems identified.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during an unknown procedure on (b)(6) 2022, the drill bit in question was found to be dull.The surgery was completed successfully after a 20 minute delay, there was no other reported patient interaction.During investigation of the returned concomitant screw, it was noted the screw was bent at the shaft.This report is for a cannulated screw.This is report 2 of 2 for (b)(4).

• Brand Name: CANNSCR Ø3.5 SELF-DRILL L48/15 SST
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16052037
• MDR Text Key: 308360415
• Report Number: 8030965-2022-11533
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205.148
• Device Lot Number: 48P9450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0