MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.017S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the reamer head on the ria2 broke during reaming twice.Seem to happen when we hit the posterior cortex of the tibia.Tried a second reamer head and broke again.It took 20-30 minutes to remove fragments of the reamer head from the canal.There were 30 minutes surgical delay.The procedure successfully completed.No patient consequences.This report is for one (1) 10.5mm reamer head for ria 2 sterile this is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: 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.
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.Additional procode: hrx date of concomitant therapy is (b)(6) , 2022.Manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument release to warehouse date: september 09, 2021 expiration date: july 31, 2031 part: 03.404.017s, 10.5mm reamer head for ria 2-sterile lot: 342p108 (sterile) production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 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: 03.404m017, ria ii reamer head 10.5mm lot: 80p5303 inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance received from mark two engineering was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Was reviewed and determined to be conforming.Heat treat results certified.Certificate of analysis supplied to mark two engineering from banner medical was reviewed and determined to be conforming.Raw material certification supplied to banner medical from carpenter was reviewed and determined to be conforming.Investigation summary: the complaint device (10.5mm reamer head for ria 2 sterile) was not received for investigation.A photo investigation was performed based on the received photos.The images were reviewed, and the complaint condition is confirmed.After review of the photos, the reamer head is found broken.The irrigation fluid tube was also found ripped.This complaint is confirmed as a photo inspection does show a broken reamer head.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the images) 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 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.G1, g4.

• Brand Name: 10.5MM 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: 13440396
• Report Number: 2939274-2022-00339
• Device Sequence Number: 4492447
• Product Code: HTO
• UDI-Device Identifier: 10886982273949
• UDI-Public: (01)10886982273949
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• 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: 03.404.017S
• Device Catalogue Number: 03.404.017S
• Device Lot Number: 342P108
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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-0572-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5MM REAMER HEAD FOR RIA 2 STERILE; UNK - REAMERS
• Patient Sex: Unknown