MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.742

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2022

Event Type  Injury  

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 are split.Particles remaining in the channel.This report involves one drive shaft-minimum 360mm length-for use with ria.This is report 1 of 2 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.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

It was noted the procedure was completed successfully with a thirty (30) minute delay.The patient status/outcome was reported as stable.

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.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

A fragment was retained in the patient.

• Brand Name: DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
• 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: 15598750
• MDR Text Key: 301722659
• Report Number: 8030965-2022-08152
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739192
• UDI-Public: 07611819739192
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.742
• Device Lot Number: H627478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 12.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR; RIA TUBE ASSEMB MIN 520 LNTH USE 314.743; RIA TUBEASSEMBLY MIN-L 360 F/314.742
• Patient Outcome(s): Required Intervention