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 Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The device was 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, while using the reamer irrigator aspirator (ria) 2 the reamer head broke from the shaft.Everything was set up correctly, running correctly, a correct technique was being used.After passing the isthmus of the tibia is when the reamer head snapped from the shaft.Fragments were dislodged in the distal tibia, unable to retrieve.There was no surgical delay reported.The procedure was successfully completed.The patient outcome was unknown.Concomitant devices reported: ria 2 reaming kit 520mm sterile (part # 03.404.001s, lot # 58p9744, quantity # 1).This complaint involves two (2) devices.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
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.E1, h6, h7, h9: 3008812560-10/26/2020-001-c.H3, h4, h6: part 03.404.017s, lot 52p8492: release to warehouse date: april 10, 2020.Expiration date: march 31, 2030.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection it was noticed that the proximal end of the reamer where it is inserted into the drive shaft has completely broken off and the broken pieces were not returned.The reported condition of embedded device was not confirmed as there is no evidence of images/x-rays are provided.No other issues were identified with the device.No dimensional inspection can be performed due to post-manufacturing damage.The relevant drawings were reviewed.The complaint condition is confirmed.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.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.D2: additional procode: hrx.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.D7: it is unknown if this single-use device was reprocessed and reused.
Event or Problem Description
It was further reported that the event in question was a revision surgery to remove a non-synthes large frag type plate.A piriformis recon nail was implanted.Insertion of the nail was performed with no issue.

• 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
• MDR Report Key: 10779402
• Report Number: 2939274-2020-04950
• Device Sequence Number: 3694558
• Product Code: HTO
• UDI-Device Identifier: 10886982273949
• UDI-Public: (01)10886982273949
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2020

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: 03.404.017S
• Device Catalogue Number: 03.404.017S
• Device Lot Number: 52P8492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 09/08/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/30/2020; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT FOR RIA 2 520MM; RIA 2 REAMING KIT 520MM STERILE; DRIVE SHAFT FOR RIA 2 520MM; RIA 2 REAMING KIT 520MM STERILE
• Outcome Attributed to Adverse Event: Required Intervention