MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number	352.251S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product code: hrx.Expiration date and lot number unknown.Complainant part is not expected to be returned for manufacturer review/investigation.It was reported that the device broke intra-operatively.An additional incision was made to remove the fragment.There was a five minute surgical delay reported and the procedure was completed as planned.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.
Event or Problem Description
It was reported that on (b)(6) 2018, the surgeon was using the reamer/irrigator/aspirator (ria) and while reaming the non union of the tibia, the reamer head broke in the canal along with a piece of the plastic reamer shaft.The surgeon was able to remove the reamer head and the broken piece of plastic from the canal.An extra incision was made to remove the piece of plastic at the entry point for the tibial nail.The reamer head was removed with reaming rod and the piece of plastic was removed through a separate incision below the patella.There was a five minutes surgical delay reported.The procedure was completed as planned.Patient outcome was unknown.Concomitant device reported: unk - nail: tibial (part#: unknown, lot#: unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.
Event or Problem Description
11/21/2018: update event description to capture 2 devices involvement: it was reported that on november 01, 2018, the surgeon was using the reamer/irrigator/aspirator (ria) and while reaming the nonunion of the tibia, the reamer head broke in the canal along with a piece of the plastic reamer shaft.The surgeon was able to remove the reamer head and the broken piece of plastic from the canal.An extra incision was made to remove the piece of plastic at the entry point for the tibial nail.The reamer head was removed with reaming rod and the piece of plastic was removed through a separate incision below the patella.There was a five-minute surgical delay reported.The procedure was completed as planned.Patient outcome was unknown.
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.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: 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8086646
• Report Number: 2939274-2018-55026
• Device Sequence Number: 199109
• Product Code: HTO
• UDI-Device Identifier: 10886982194442
• UDI-Public: (01)10886982194442
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2018

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: 352.251S
• Device Catalogue Number: 352.251S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 12/21/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/10/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 96