MAUDE Adverse Event Report: SYNTHES GMBH RIB HOOK LONG; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.010

Device Problem Material Integrity Problem (2978)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Device report from synthes 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) rib hook long this is report 1 of 2 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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 # 04.641.010 synthes lot # 7867482 supplier lot #na release to warehouse date: 3 dec 2014.Manufactured by: synthes brandywine 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 the "long rib hook body" of the rib hook long was found broken.The broken fragment was returned.No other issues were observed.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.The overall complaint was confirmed as the observed condition of the rib hook long [04.641.010/7867482] 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.G1: manufacturing site name & address corrected.

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.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: RIB HOOK LONG
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1301 goshen parkway; west chester CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16769771
• MDR Text Key: 313597941
• Report Number: 8030965-2023-04926
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819352858
• UDI-Public: (01)07611819352858
• 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: 04.641.010
• Device Lot Number: 7867482
• 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: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLOSURE F/EXTENSION BAR TAN GOLD.
• Patient Sex: Male