MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.022S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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) 2020, while harvesting bone graft right femur, the reamer irrigator aspirator (ria) had trouble making the turn around the medial cortex, and the head tines sheared off.The surgeon retrieved the broken pieces, and continued with a new kit.Fragments were removed easily without additional intervention.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed.There was no patient consequences.This is report 3 of 3 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.D2: additional procode: hrx.H6: part: 03.404.022s.Synthes lot: 33p1495.Supplier lot: 33p1495.Expiration date: november 30, 2029.Release to warehouse date: december 10, 2019.Supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 13.0MM 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
• MDR Report Key: 10534889
• Report Number: 2939274-2020-04122
• Device Sequence Number: 3872899
• Product Code: HTO
• UDI-Device Identifier: 10886982274021
• UDI-Public: (01)10886982274021
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 03.404.022S
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 33P1495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/20/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 13.0MM REAMER HEAD FOR RIA 2 STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Age: 6 DA
• Patient Weight: 77