MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/48MM; SCREW, FIXATION, BONE

Model Number 02.127.148

Device Problem Material Integrity Problem (2978)

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

Event Date 06/22/2022

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional procode: hr.A manufacturing record evaluation cannot be performed due to lot number being unknown.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that va lockscr ø3.5 self-tap l48 sst had the edges of the threads head screw peeled and the recess head was noted worn.A dimensional inspection for the va lockscr ø3.5 self-tap l48 sst was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 of the va lockscr ø3.5 self-tap l48 sst 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 colombia reports an event as follows: it was reported that on (b)(6) 2022, the screw in question was found with a bare head and damaged stardrive.There was no reported adverse patient interaction.No further information is available.This report is for a 3.5mm variable angle locking screw/slf-tpng/strdrv/48mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/48MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16291952
• MDR Text Key: 308770917
• Report Number: 8030965-2023-01351
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982043283
• UDI-Public: (01)10886982043283
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.127.148
• Device Catalogue Number: 02.127.148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male