MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE ADAPTION PLATE/6 HOLES/0.5MM THICK; PLATE, BONE

Catalog Number 04.503.344

Device Problem Break (1069)

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

Event Date 02/04/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.

Event Description

Device report from synthese reports an event in china as follows: it was reported that on (b)(6) 2023, the plate broke.It was reported that during the surgery, noted the plate was broken off.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) adaptpl 6ho t0.5 ti this is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part:04.503.344.Lot:91p3617.Release to warehouse: 19 feb, 2021.Manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the adaptpl 6ho t0.5 ti, p/n: 04.503.344, lot: 91p3617, was broken at the edge of one of the locking holes.The broken fragment was observed in the provided evidence.No other problems identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for adaptpl 6ho t0.5 ti, p/n: 04.503.344, lot: 91p3617.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.G1: manufacturing site name and address.

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: 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 adaptpl 6ho t0.5 ti was broken across the screw insertion hole #3 from left to right.The device was received cut across holes #1 & #2 from the other side, fragment was not returned.The matrixmidface¿ plate and screw system surgical technique guide was reviewed.Following relevant statements were found.Precautions: ¿ if contouring is necessary, the surgeon should avoid bending the device at a screw hole.¿ avoid sharp bends, repetitive and reverse bending as it increases the risk of implant breakage.The review has also shown that for out of plane bending like in this case either the 03.503.035 bending pliers 3d for matrixmidface plates or the 03.503.038 bending pliers for matrixmidface plates should be used.While a root cause cannot be determined for the reported issue, it is possible that the plate was bent in an inappropriate direction leading to the breakage.A dimensional inspection for the adaptpl 6ho t0.5 ti 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 adaptpl 6ho t0.5 ti would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 drawings reflecting the current and manufactured revisions were reviewed: adaption plate 6 holes matrix midface 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: TI MATRIXMIDFACE ADAPTION PLATE/6 HOLES/0.5MM THICK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16664254
• MDR Text Key: 312893414
• Report Number: 8030965-2023-04005
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819917309
• UDI-Public: (01)07611819917309
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050608
• 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
• Report Date: 04/03/2023

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: 04.503.344
• Device Lot Number: 91P3617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 06/08/2023
• Supplement Dates FDA Received: 04/20/2023; 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1