MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMING ROD PUSH ROD 2.5MM SHAFT; REAMER

Model Number	SD03.010.093
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) 2020, two (2) auto-adjusting drive adaptor broke during surgery, two (2) screwdrivers stripped during a process of screw, the screw interlock with the screw head and was stripped., and two (2) reaming rod push rod 2.5mm shaft broke off.The procedure was successfully completed with surgical delay of 5 minutes.There were no fragments generated.There was patient consequence reported.Concomitant device reported: unknown screw (part# unknown; lot# unknown; quantity: 1).This complaint involves six (6) devices.This report involves one (1) reaming rod push rod 2.5mm shaft.This report is 3 of 4 for (b)(4).

• Brand Name: REAMING ROD PUSH ROD 2.5MM SHAFT
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11194797
• Report Number: 2939274-2021-00358
• Device Sequence Number: 767020
• Product Code: HTO
• UDI-Device Identifier: 10886982002570
• UDI-Public: (01)10886982002570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: SD03.010.093
• Device Catalogue Number: SD03.010.093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAMING ROD PUSH ROD 2.5MM SHAFT; STR/HXDR SCWDR SFT T25 3.5MM HEX/SLF-RTN 165MM; STR/HXDR SCWDR SFT T25 3.5MM HEX/SLF-RTN 165MM; UNK - POWERED DRIVERS/HANDPIECES; UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWS: TRAUMA