MAUDE Adverse Event Report: SYNTHES GMBH 11.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.018S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent an trauma procedure on (b)(6) 2024.The customer used ria 2.The reamer head broke and four pieces of metal were in the femur.It was hard to get all fragments but finally they were all removed.Procedure was completed successfully with a delay of thirty five minutes.There was no patient consequence.This report is for a 11.0mm reamer head for ria 2 sterile.
Additional 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.H11 additional narrative: h3, h4, h6: photo investigation: the product was not returned to j&j medtech orthopaedics; however photos were provided for review.The photo/x-ray investigation revealed that the prongs of the proximal end of the device were broken.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the 11.0mm reamer head for ria 2 sterile would contribute to the complained device issue.The cause of this issue was identified as deviation from the recommended surgical approach of 10 degrees.No new malfunctions were observed during this investigation that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities device history review (dhr): manufacturing location: elmira / inspected and packaged by: monument release to warehouse date: 03-jul-2024.Expiration date: 01-jun-2034.Part number: 03.404.018s, 11.0mm reamer head for ria 2 sterile.Lot number: 24489p2.Lot quantity: 50.Component part(s) reviewed: part number: 03.404m018sp, ria 2 reamer head 11.0mm.Lot number: 16021p1.Lot quantity: 100.This lot met all dimensional, visual, sterilization, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20368468
• Report Number: 8030965-2024-12472
• Device Sequence Number: 6859730
• Product Code: HTO
• UDI-Device Identifier: 10886982273963
• UDI-Public: (01)10886982273963(17)340601(10)24489P2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.404.018S
• Device Lot Number: 24489P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT F/RIA 2 L520
• Patient Sex: Unknown