MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMAND RECO-PL STRAIG 20HO T2.5 TI; PLATE, BONE

Catalog Number 04.503.738

Device Problem Break (1069)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in china as follows: it was reported that a plate broke during surgery.Another device was used to complete the surgery.There were no adverse consequences to the patient.No fragments generated.Procedure was successfully completed without any surgical delay.No additional information could be provided.This report is for one (1) matrixmand reco-pl straig 20ho t2.5 ti this is report 1 of 1 for complaint (b)(4).

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.State: (b)(6).Phone #(b)(6).The photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the matrixmand reco-pl straig 20ho t2.5 ti had broken between screw holes #5 and #6 from left to right.The matrixmandible plate and screw system surgical technique guide se_807064 rev.Af was reviewed.Following relevant statements were found.Warning: - these devices can break intraoperatively when subjected to excessive forces or outside the recommended surgical technique.Precaution: - minimize notching or scratching of the implant during contouring.These factors may produce internal stresses which may become the focal point for eventual breakage of the implant.Precautions: - avoid reverse bends as it may weaken the plate and lead to premature implant failure.- avoid sharp bends.Sharp bends include a single out-of plane bend of >30 degrees between two adjacent holes notes: - excessive bending would include bends that exceed the range typical for adapting to the mandible e.G.>20 degrees in torsion and ¿in-plane¿ bending, and >30 degrees ¿out-of-plane¿ bending.The review has also shown that for out of plane bending, either the bending irons 03.503.077 and 03.503.078 or the bending pliers with nose 03.503.056 should be used.If the bending pliers with nose is used the out of plane and second step marked part of the tool has to be used.The duckbill end of the bending pliers with nose is used to bent the last segment of a plate, which is accordingly marked on the device.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.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 synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the matrixmand reco-pl straig 20ho t2.5 ti.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Device history review part# 04.503.738 lot # 385p119 manufacturing site: werk selzach logistik supplier: na release to warehouse date: (b)(6) 2021 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 matrixmand reco-pl straig 20ho t2.5 ti, p/n: 04.503.738, lot: 385p119, was broken.The broken fragments were returned for evaluation.The breakage was located at the surface between two locking holes.No other problems identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 matrixmand reco-pl straig 20ho t2.5 ti, p/n: 04.503.738, lot: 385p119 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.

• Brand Name: MATRIXMAND RECO-PL STRAIG 20HO T2.5 TI
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH LOGISTIK; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16586334
• MDR Text Key: 312008492
• Report Number: 8030965-2023-03513
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819973893
• UDI-Public: (01)07611819973893
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.738
• Device Lot Number: 385P119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA