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

Catalog Number 04.641.010

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2022, the nut of the rib hook could not be tightened on the rib hook with the socket wrench.There was surgical delay of five (5) minutes.No adverse patient consequences.Patient outcome is fine.This report involves one (1 ) long ti rib hook.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.Part# 04.641.010, synthes lot# 6939936, supplier lot# n/a, release to warehouse date: 09 may2012, manufactured by: synthes (b)(4).No ncrs were generated during production.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.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 threads of the barrel were found stripped, the stripped condition contributed to the nut not being able be fully seat.No other issues were observed.A dimensional inspection was not performed due to post manufacturing damage.A functional test was performed, the nut cannot be fully threaded in the rib hook long, due the threads of the barrel being stripped.The complaint condition was able to be replicated.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/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 rib hook long 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.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: LONG TI RIB HOOK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15683173
• MDR Text Key: 307024038
• Report Number: 8030965-2022-09015
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819352858
• UDI-Public: (01)07611819352858
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 6939936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Male