MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM; PLATE, BONE

Model Number 04.503.642.01

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/09/2022

Event Type  Injury  

Event Description

Device report from brazil reports an event as follows: it was reported that on (b)(6) 2022 the surgeon removed the implants from the first surgery as the implants were damaged inside the patient.No information is known on patient status.This report is for a 2.4 mm ti matrixmandible locking screw slf-tpng 12 mm.This is report 6 of 9 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 04.503.642.01c synthes lot # h143734 supplier lot # n/a release to warehouse date:18 july 2016 manufactured by: synthes monument no ncrs were generated during production.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 there was no damage or defects with the lock scr ø2.4 self-tap l12 tan 1u i/clip.Only was observed signs of usage and normal worn which could have been a result of implantation and explantation.No broken condition was found.A dimensional inspection was performed for the lock scr ø2.4 self-tap l12 tan 1u i/clip and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the lock scr ø2.4 self-tap l12 tan 1u i/clip was found to have no damage or defects.No definitive root cause could 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM
• Type of Device: PLATE, 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: 15562566
• MDR Text Key: 301349904
• Report Number: 8030965-2022-07962
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587022215
• UDI-Public: (01)10887587022215
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.642.01
• Device Catalogue Number: 04.503.642.01C
• Device Lot Number: H143734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IMF SCREW Ø2 L8 SST; IMF SCREW Ø2 L8 SST; LOCK SCR Ø2.4 SELF-TAP L10 TAN 1U I/CLIP; MATRIXMAND RECO-PL ANGL R 7+23HO T2.5 TI
• Patient Outcome(s): Required Intervention
• Patient Sex: Male