MAUDE Adverse Event Report: SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.016S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter is j&j company representative.H4 device history.Manufacturing location: supplier ¿ (b)(4) / inspected and packaged by: monument.Release to warehouse date: 10-may-2022.Expiration date: 31-mar-2032.Part number: 03.404.016s, 10.0mm reamer head for ria 2-sterile.Lot number: 779p421 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 22401 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404m016, ria 2 reamer head 10.0mm.Lot number: 552p132.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance received from mark two engineering dated (b)(6) 2022 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated (b)(6) 2022 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 54-55 hrc.Certificate of analysis supplied to mark two engineering from banner medical dated (b)(6) 2020 was reviewed and determined to be conforming.Raw material certification supplied to banner medical from dunkirk specialty steel dated (b)(6) 2020 was reviewed and determined to be conforming.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 or Problem Description
It was reported during a tibial nail procedure on (b)(6) 2024, during reaming, the clips on reamer broke were left in bone.During the case the tint on reamer head part broke off in the patient.A surgical delay of 15 minutes occurred due to trying to remove the fragments.The procedure was completed successfully but 3 tines of the reamer head were left in the medullary canal of the tibia.This report is for one 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 19761355
• Report Number: 8030965-2024-08818
• Device Sequence Number: 8604831
• Product Code: HTO
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K993335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.404.016S
• Device Lot Number: 779P421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown