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

Model Number SD03.010.093

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

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 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
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11194797
• MDR Text Key: 227570216
• Report Number: 2939274-2021-00358
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982002570
• UDI-Public: (01)10886982002570
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SD03.010.093
• Device Catalogue Number: SD03.010.093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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