MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.018S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2022, while performing a ria, two of the 11mm reamer heads broke and fragments of the splines were retained inside of the patient.The tibia canal was very small and the surgeon commented the bone was very hard.Procedure was completed successfully with a thirty(30) minutes of surgical delay.Fragments were generated and no patient consequences.This report is for one (1) 11.0mm reamer head for ria 2 sterile.This is report 2 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4.Expiration date.H6 - codes updated to imdrf codes.Device history lot: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument.Release to warehouse date: 24-sep-2021.Expiration date: 31-aug-2031.Part number: 03.404.018s, 11mm reamer head for ria 2-sterile.Lot number: 96p3940 (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.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(6) 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: 03.404.M018, ria ii reamer head 11.0mm.Lot number: 7095002.Lot quantity:(b)(6) total (248 and 49).Jbl-nr-0005795 was initiated at incoming inspection for undersized cannulation diameters.The lot was 100% inspected for this feature and a total of (b)(6) pieces were dispositioned ¿release from hold¿; the remaining 48 pieces were dispositioned ¿rtv¿.Inspection instructions met all inspection acceptance criteria apart from the 48 pieces noted.Inspection sheets, incoming final inspection, ns073690 rev b met all inspection acceptance criteria apart from the 48 pieces noted.Certificates of compliance received from mark two engineering dated 28-aug-2020 and 11-dec-2020 were reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated 17-aug-2020 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 52 hrc.Certificate of analysis supplied to mark two engineering from banner medical dated 04-may-2020 was reviewed and determined to be conforming.Raw material certificate of tests supplied to banner medical from carpenter dated 11-jun-2019 was reviewed and determined to be conforming.Device history review - 01-feb-2022: dhr reviewed by: mschoenfeld.This lot met all dimensional, visual, sterility and packaging criteria 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.

• Brand Name: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13523707
• Report Number: 2939274-2022-00466
• Device Sequence Number: 19929679
• Product Code: HTO
• UDI-Device Identifier: 10886982273963
• UDI-Public: (01)10886982273963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Device Lot Number: 96P3940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 93 KG