MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM REAMING ROD PUSHER 450MM LONG; REAMER

Model Number	SD03.010.094
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the cutter for titanium elastic nails was broken, two (2) 2.7mm reaming rod pusher 450mm long and one (1) helical blade/ screw measuring device piece were broken off.While, the stardrive screwdriver shaft t25 3.5mm hexagonal/ self-retain and cannulated 3.5mm hexagonal screwdriver shaft head were stripped.There was a surgical delay of a couple of minutes.Fragments were generated and instruments were removed.It is unknown if procedure was successfully completed.There is patient involvement.This is report 4 of 5 for (b)(4).

• Brand Name: 2.7MM REAMING ROD PUSHER 450MM LONG
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10928619
• Report Number: 2939274-2020-05384
• Device Sequence Number: 2469788
• Product Code: HTO
• UDI-Device Identifier: 10886982258595
• UDI-Public: (01)10886982258595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: SD03.010.094
• Device Catalogue Number: SD03.010.094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: 2.7MM REAMING ROD PUSHER 450MM LONG; CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT; CUTTER FOR TI ELASTIC NAILS; HELICAL BLADE/SCREW MEASURING DEVICE