MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM; PLATE, BONE

Model Number 04.503.410.01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in italy as follows: it was reported that on (b)(6), 2022, the screw broke off as it was threaded in, securing the fixation plate to the mandible.It was impossible to remove the part screwed to the bone.As a consequence, it might be difficult to remove the plate in the future.No further information is available.This report involves one2.0mm ti matrixmandible screw self-tapping 10mm.This is report 1 of 1 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.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product code: 04.503.410.01s, lot no: 893p739, manufacturing site: jabil bettlach, release to warehouse date:05/07/2022, expiry date: 01/06/2032.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 the matmand scr ã¸2 self-tap l10 tan 1u i/cli was broken from the distal tip, fragment was not returned.Additionally, the threads are peeled off.Embedded device condition cannot be confirmed since x-ray evidence was not provided.The instructions for use for the matrixmandible plating system was reviewed.Following relevant statement was found.Warnings: - these devices can break intraoperatively when subjected to excessive forces or outside the recommended surgical technique.- do not use excessive force during screw insertion.Do not overtighten screws.Precautions: - tighten screws in a controlled manner.Applying too much torque to the screws may cause screw/plate deformation, or bone stripping.While no root cause can be determined for the reported issue, the breakage condition of the screw was consistent with a random component failure that may have been caused by exposure to unintended forces during implantation.A dimensional inspection for the matmand scr ã¸2 self-tap l10 tan 1u i/cli was unable to be performed due to post manufacturing damage.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 matmand scr ã¸2 self-tap l10 tan 1u i/cli 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.If information is obtained that was not available for this 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.D9.

• Brand Name: 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16296610
• MDR Text Key: 308963284
• Report Number: 8030965-2023-01378
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587020587
• UDI-Public: 10887587020587
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063790
• 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,Followup,Followup

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 Model Number: 04.503.410.01
• Device Catalogue Number: 04.503.410.01S
• Device Lot Number: 893P739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 03/01/2023
• Supplement Dates FDA Received: 02/27/2023; 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: TRAUMA
• Patient Age: 55 YR