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	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional procode: hrx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 during a procedure on (b)(6) 2022, the reamer heads for reamer irrigator aspirator (ria) 2 broke off while harvesting bone graft from the left femur.X-ray confirmed that all fragments were retrieved.The procedure was successfully completed with a ten minute delay.There was no patient consequence.This report is for a 14.0mm reamer head for ria 2 sterile.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 14.0mm reamer head for ria 2 steril (p/n: 03.404.024s) was broken, since it is observed the tangs of the reamer head are broken off.The fragments of the piece were returned and no other issues were identified.A dimensional inspection for the 14.0mm reamer head for ria 2 sterile was not performed at juarez lab due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 14.0mm reamer head for ria 2 steril (p/n: 03.404.024s) would contribute to the complained device issue.Due to the trend with the broken ria 2 reamer heads identified during post market surveillance, the capa was raised to determine the root cause of broken head breakages.Additionally, the product issue escalation (pie) 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.No device history review was performed since the lot number was not provided.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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13509601
• Report Number: 2939274-2022-00418
• Device Sequence Number: 4064160
• Product Code: HTO
• UDI-Device Identifier: 10886982274069
• UDI-Public: (01)10886982274069
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 12.0MM REAMER HEAD FOR RIA 2 STERILE
• Patient Sex: Male