MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a j&j sales representative.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 an unknown date, during a surgical procedure, a reamer head broke off of drive shaft while reaming.It was replaced with a smaller diameter reaming head.There was no patient consequence reported.This report is for one (1) 14.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.Visual inspection: the 14.0mm reamer head for ria 2 sterile (part# 03.404.024s, lot#234p550, qty# 1) was returned and received at us cq.Upon visual inspection, it was observed that the reamer head prongs were broken and the broken fragments were returned.No other issues were identified.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to post manufacturing damage.Document/specification review: no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for 14.0mm reamer head for ria 2 sterile (part# 03.404.024s, lot#234p550, qty# 1).Due to the trend with the broken ria 2 reamer heads identified during post market surveillance, the capa-010231 was raised to determine the root cause of broken head breakages.Additionally, the product issue escalation (pie 1871936) was initiated to define any further action related to the breakage.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 lot - manufacturing location: supplier ¿ (b)(4)/ inspected and packaged by: monument release to warehouse date: 12-aug-2021 expiration date: 30-jun-2031 part number: 03.404.024s, 14.0mm reamer head for ria 2-sterile lot number: 234p550 (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 20408 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: 03.404m024, ria 2 reamer head 14.0mm lot number: 7122002 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073690 rev b met all inspection acceptance criteria.Certificate of compliance received from mark two engineering dated 30-oct-2020 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated 17-sep-2020 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 53 hrc.Certificate of analysis supplied to mark two engineering from banner medical dated 14-may-2020 was reviewed and determined to be conforming.Raw material certification supplied to banner medical from carpenter dated 20-apr-2020 was reviewed and determined to be conforming.Device history review - 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: 14.0MM 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12924553
• Report Number: 2939274-2021-06952
• Device Sequence Number: 5568800
• Product Code: HTO
• UDI-Device Identifier: 10886982274069
• UDI-Public: (01)10886982274069
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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 Model Number: 03.404.024S
• Device Catalogue Number: 03.404.024S
• Device Lot Number: 234P550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0579-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RIA: DRIVE SHAFT
• Patient Sex: Unknown