MAUDE Adverse Event Report: SYNTHES GMBH CLOSURE F/EXTENSION BAR TAN GOLD; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

Device Problem Compatibility Problem (2960)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Device report from synthese reports an event in japan as follows: it was reported that this was a surgery on left and right sides using veptr 2 system for symptomatic scoliosis on (b)(6) 2023.The patient was a boy with severe kyphosis.Right side viewed from posterior was treated properly by rib-to-lamina with devices.The following event occurred while the surgeon was treating left side.At t9 and t10, when the surgeon grabbed 2 ribs with the rib hook and hit a holder with a hammer to lock with the closure, the surgeon said that the closure looked like it was set misaligned.The sales rep suggested the surgeon replace the closure, but the surgeon continued the procedure saying replacement was difficult and the closure might only look like it was misaligned.When the surgeon grasped a proximal extension with a holder to connect it to the rib hook, the surgeon noticed that the rib hook was broken, so the surgeon removed the closure and the broken rib hook.After that, the surgeon used substitutes and completed the surgery successfully with about 10 minutes delay.There were no problems in surgical technique, and the surgeon was an expert on the devices.The patient is stable.No further information is available.This report is for one (1) closure f/extension bar tan gold.This is report 2of 2 for complaint (b)(4).

Manufacturer Narrative

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h6: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 497.125.Lot no: 828p684.Release to warehouse date: 14 jun, 2022.Manufacturing site: werk selzach.Supplier: synthes usa hq, inc.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 evidence of heavy use and wear due to used, the observed damage can be attributed to a combination of heavy usage and impacting the device with other tool.The wear condition can be affect the device functionality, however is not possible determinate the root cause of the device interaction allegation.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the mating device was returned but that is broken.The overall complaint was confirmed as the observed condition of the closure f/extension bar tan gold 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.H3, h6: the device was 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.

• Brand Name: CLOSURE F/EXTENSION BAR TAN GOLD
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16769779
• MDR Text Key: 313599950
• Report Number: 8030965-2023-04929
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747289
• UDI-Public: (01)07611819747289
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142587
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.125
• Device Lot Number: 828P684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RIB HOOK LONG
• Patient Sex: Male