MAUDE Adverse Event Report: MONUMENT DEPUY SYNTHES PRODUCTS INC RIA 2 REAMING KIT 520MM STERILE; REAMER

Catalog Number	03.404.001S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bone harvesting procedure on a proximal tibia non-union using the ria2 system, the tube assembly encountered resistance at the non-union site, necessitating additional force to extract it from the canal.Upon removal, it was observed that the tube assembly had sustained damage, with a clean cut approximately 3-4 cm from the reamer head coupling point.A replacement tube assembly was immediately available, and the procedure continued.However, this newly opened tube assembly also became lodged at the non-union site, requiring further pulling to disengage it from the surrounding bone fragments.Unfortunately, this second tube assembly was found to be more severely damaged, resulting in multiple fragments.Despite these challenges, the bone harvesting procedure was successfully completed, and the case proceeded as planned.Surgery was delayed 10 minutes due to the reported event and the procedure successfully completed.
Additional Manufacturer Narrative
Product complaint (b)(4).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: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: added: b5, h4 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
Additional information received states that there was no other intervention was required.
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.Device history review: manufacturing location: packaged, sterilized and released by: monument, release to warehouse date: 6-may-2024, expiration date: 31-mar-2026, part number: 03.404.001s-us, ria 2 reaming kit 520mm sterile, lot number: 16434p7 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll), lppf rev b, lmd rev b was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 28704 supplied by (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404m014, irrigation tubing set, lot number: 9482p22, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Incoming final inspection, ns073691, rev a met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4) products dated 18-jan-2024 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set, lot number: 12920p6, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073692 rev a met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4) products dated 11-mar-2024 was reviewed and determined to be conforming.Part number: 03.404m001, rmg rod/drive shaft packaged, lot number: 17392p0, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m012, ria ii ream rod/dr shaft seal, lot number: 11659p8, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073695 rev a met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 1-mar-2024 was reviewed and determined to be conforming.Part number: 03.404m003, manifold assembly packaged, lot number: 15981p2, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m010, ria ii manifold assembly, lot number: 8728p63, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Incoming final inspection, ns073694, rev e met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 16-nov-2023 was reviewed and determined to be conforming.Note: the supplier lot number documented on the jabil receiving document is (b)(4), but the lot number notated on the certificate of conformance.18-nov-2024: dhr reviewed: this lot met all dimensional, visual, sterility 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: RIA 2 REAMING KIT 520MM STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): MONUMENT DEPUY SYNTHES PRODUCTS INC; 1101 synthes avenue; monument CO 80132
• 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: 20659290
• Report Number: 1719045-2024-00005
• Device Sequence Number: 12584277
• Product Code: HTO
• UDI-Device Identifier: 10886982274229
• UDI-Public: (01)10886982274229(17)260331(10)16434P7
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Expiration Date: 03/31/2026
• Device Catalogue Number: 03.404.001S
• Device Lot Number: 16434P7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/28/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/26/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown