MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Catalog Number 03.404.035

Device Problem Material Integrity Problem (2978)

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

Event Date 07/22/2023

Event Type  malfunction  

Event Description

Device report from colombia reports an event as follows: it was reported that following a procedure on (b)(6) 2023, when irrigating the drive shaft to wash, it presented damage.Upon manufacturer investigation, it was determined that the device was broken into pieces.This report is for a drive shaft for ria 2 520mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procode: hrx e1: phone number reported as (b)(6).E3: reporter is a synthes employee.H3, h6: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.The product was not returned to depuy synthes, however photos were received for review.The photo investigation revealed that the device 03.404.035, drive shaft f/ria 2 l520 was broken into pieces.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Based on the reported condition, a dimensional inspection and document/specification review were not required.The overall complaint was confirmed as the observed condition of the device 03.404.035, drive shaft f/ria 2 l520 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life identified and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

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.H4, h6: part 03.404.035, lot j000992: release to warehouse date: april 23, 2021.Supplier: (b)(4).No non-conformance reports (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.D9, h3, h6: a product investigation was completed: visual analysis of the returned sample revealed that drive shaft was found broken from the shaft.The broken fragment was returned for evaluation.While no root cause can be determined for the reported issue, the breakage condition of the drive shaft was consistent with a random component failure that may have been caused by exposure to unintended forces.Ensuring proper handling of the device is recommended to avoid breakage.The drawings reflecting the current and manufactured revisions were reviewed.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: DRIVE SHAFT FOR RIA 2 520MM
• Type of Device: REAMER
• 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: 17691328
• MDR Text Key: 322744497
• Report Number: 8030965-2023-11176
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334143037
• UDI-Public: (01)07612334143037
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111437
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.035
• Device Lot Number: J000992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1