MAUDE Adverse Event Report: SYNTHES GMBH LOCK SCR 2 SELF-TAP L6 TAN 4U I/CLIP; PLATE, BONE

Catalog Number 04.503.606.04S

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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, during a procedure the surgeon was not able to tighten the screw to the plate.Procedure was completed with a replacement which was tightened to the same plate.This report is for one (1) 2.0mm ti matrixmandible locking screw slf-tpng 6mm.This is report 1 of 2 for complaint (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: part: 04.503.606.04s, lot: 89p0537, manufacturing site: bettlach, release to warehouse date: 09 february 2021, expiry date: 01 february 2031.A manufacturing record evaluation was performed for the finished good lot and no non-conformances were identified.The product was returned to us customer quality (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 4u i/clip the thread of the screw was slightly deformed at the neck and no other issues were identified.The dimensional inspection was not performed due post manufacturing damage.Functional test cannot be performed as the device was received by itself.The alleged will not lock condition can be confirmed since the device was slight deformed at the neck.The observed condition of lock scr ø2 self-tap l6 tan 4u i/clip in the device was consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for lock scr ø2 self-tap l6 tan 4u i/clip.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: -2.0mm mandible self-tapping locking matrix mandible system 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

This report is for a lock scr ø2 self-tap l6 tan 4u i/clip.

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.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.G4: device is not distributed in the united states, but is similar to device marketed in the usa.

• Brand Name: LOCK SCR 2 SELF-TAP L6 TAN 4U I/CLIP
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12132363
• MDR Text Key: 261004244
• Report Number: 8030965-2021-05602
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939714
• UDI-Public: (01)07611819939714
• 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: 06/14/2021

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
• Device Lot Number: 89P0537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 07/07/2021; 07/20/2021
• Supplement Dates FDA Received: 07/19/2021; 08/13/2021
• Patient Sequence Number: 1
• Treatment: UNK PLATE; UNK SCREWDRIVER