MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM; PLATE, BONE

Catalog Number 04.503.606.04S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during the procedure the surgeon was not able to tighten the locking screw to the plate in the mandible.Another screw was used to tighten the plate.This report involves (1) 2.0mm ti matrixmandible locking screw slf-tpng 6mm.This is report 3 of 3 for (b)(4).

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.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that lock scr ø2 self-tap l6 tan no issues were identified in the visual inspection.The dimensional inspection was not performed due to in accessible feature.Functional test cannot be performed since the device was received by itself but the alleged unable to assemble condition cannot be confirmed since no issues were identified with the device.The observed condition of lock scr ø2 self-tap l6 tan in the device was not consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for lock scr ø2 self-tap l6 tan.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition.There was no indication that a design or manufacturing issue contributed to the complaint.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.

• Brand Name: 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12175670
• MDR Text Key: 263423493
• Report Number: 8030965-2021-05789
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.606.04S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/20/2021; 09/01/2021
• Supplement Dates FDA Received: 08/17/2021; 10/01/2021
• Patient Sequence Number: 1
• Treatment: LOCK SCR Ø2 SELF-TAP L6 TAN.; UNKNOWN - PLATE.