MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)

Model Number	309.068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer 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.Without a lot number the device history records review could not be completed.Product was not returned.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) 2019, during left total knee arthroscopy, while trying to get a screw out of the device that was used to take out a previous screw, it broke into a few pieces.The device was hard to use.Fragments were removed successfully.There was no surgical delay reported.Procedure was successfully completed.There was no harm to the patient.Concomitant devices reported: unknown drill bits: trauma (part# unknown, lot# unknown, quantity# unknown).Unk - centering pin: trauma (part# unknown, lot# unknown, quantity# 1).Unknown flexible shafts (part# unknown, lot# unknown, quantity# 1) this report is for 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.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: SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9298511
• Report Number: 2939274-2019-62053
• Device Sequence Number: 2132012
• Product Code: HTO
• UDI-Device Identifier: 10886982185587
• UDI-Public: (01)10886982185587
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/22/2019

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: 309.068
• Device Catalogue Number: 309.068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CENTERING PIN: TRAUMA; UNK - DRILL BITS: TRAUMA; UNK - FLEXIBLE SHAFTS
• Patient Age: 56 YR
• Patient Weight: 119