MAUDE Adverse Event Report: SYNTHES GMBH 10.5MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.017S
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	12/08/2023
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.D2: additional procode: hrx.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on (b)(6) 2023, the patient had an irrigation and debridement of the tibia, there was a removal of hardware and antibiotic nail.During the procedure while using the ris bone harvesting kit it was noticed that small pieces of the reamer heads were breaking off in the intermedullary canal of the patient's left tibia.Attempts were made to remove the fragments under c-arm.Several small fragments were visible at the ankle.No additional information is available.This report is for a 10.5mm reamer head for ria 2 sterile.This is report 1 of 5 for (b)(4).
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.H6: device history record (dhr) review conducted: manufacturing location: supplier ¿ (b)(4)/inspected and packaged by: monument.Release to warehouse date: 09-apr-2020.Expiration date: 28-feb-2030.Part number: 03.404.017s-us, 10.5mm reamer head for ria 2-sterile.Lot number: 51p1154 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf rev a, lmd rev a was reviewed and determined to be conforming after rework.Packaging boms were reviewed and determined to be conforming with no deviations to normal packaging identified.Scn was reviewed and determined to be conforming.This lot met all dimensional, visual, 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: 03.404m018, ria ii reamer head 10.5mm.Lot number: 6911004.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance dated 23-mar-2020 was reviewed and determined to be conforming.Certification for heat treat dated 31-jan-2020 was reviewed and determined to be conforming.Raw material certification dated 24-sep-2019 was reviewed and determined to be conforming.Raw material certificate of tests dated 11-jun-2019 was reviewed and determined to be conforming.This lot met all dimensional, visual, 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.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
This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.

• Brand Name: 10.5MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: 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: 18536707
• Report Number: 8030965-2024-01037
• Device Sequence Number: 7773046
• Product Code: HTO
• UDI-Device Identifier: 10886982273949
• UDI-Public: (01)10886982273949
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 03.404.017S
• Device Lot Number: 51P1154
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.0MM REAMER HEAD FOR RIA 2 STERILE.; 10.0MM REAMER HEAD FOR RIA 2 STERILE.; 11.0MM REAMER HEAD FOR RIA 2 STERILE.; 11.0MM REAMER HEAD FOR RIA 2 STERILE.
• Patient Sex: Unknown