MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS; GUIDE

Model Number	324.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j 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 an unknown date, the insertion sleeves are failing to seat into holes in the aiming arm and the power driver shaft is getting stuck inside the tube during insertion and when removing the power driver.It is unknown if there were patient and procedure involvement.Concomitant device reported: unk: guides/sleeves/aiming: aiming arm (part# unknown; lot# unknown; quantity: unknown).This complaint involves (6) devices.This report is for (1) insertion sleeve for 5.0 ti lckng screws.This report is 2 of 4 for (b)(4).

• Brand Name: INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12259348
• Report Number: 2939274-2021-04432
• Device Sequence Number: 3635671
• Product Code: FZX
• UDI-Device Identifier: 10886982190949
• UDI-Public: (01)10886982190949
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2021

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: 324.022
• Device Catalogue Number: 324.022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS; INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS; INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - POWERED DRIVERS/HANDPIECES: E-PEN: TRAUMA