MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; ARTHROSCOPE

Catalog Number 314.743

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/22/2022

Event Type  malfunction  

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.Additional narrative: procode: additional device product codes: hto.Initial reporter occupation: reporter is a j&j employee.Part# 314.743, synthes lot#: h890677, supplier lot#: h890677, release to wrehouse date: 23 jul 2020, supplier: criterion tool & die, inc.No ncr's 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 the tip of ria driveshaft l520, p/n: 314.743, was broken.The broken fragment was not returned for evaluation.No other problems identified.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.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 ria driveshaft l520, p/n: 314.743 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.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.

Event Description

Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the end of the l360 drive shaft and the legs of the 12 mm ria milling cutter split.Particles remained in the channel.There was a 30-minute delay in relation to the reported event.The surgery was successfully completed, and the patient status/outcome was reported as ok.A fragment remained in the patient.No further information is available.This report involves one drive shaft-minimum 520mm length-for use with ria.This is report 3 of 3 for (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16195904
• MDR Text Key: 309036204
• Report Number: 8030965-2023-00616
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07611819739208
• UDI-Public: 07611819739208
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: H890677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 12.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR; RIA TUBEASSEMBLY MIN-L 360 F/314.742