MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE,DEPTH

Model Number 319.04

Device Problem Break (1069)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.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 unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) depth gauge for 2.7mm & small screws this report is 11 of 14 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a (b)(6) representative.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 unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) depth gauge for 2.7mm & small screws this report is 11 of 14 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13196841
• MDR Text Key: 285710323
• Report Number: 2939274-2022-00074
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189974
• UDI-Public: (01)10886982189974
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.04
• Device Catalogue Number: 319.04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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: 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT 620MM; DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; GRPC CASE FOR 3.5/4.0MM CMBND CANULD SCRW SET; GRPHIC CSE FOR 3.5/4.0MM COMBND CANNLTED SCRW SET; HELICAL BLADE/SCREW COUPLING SCREW; HOLD-FORCEPS F/SYNREAM REAMING ROD Ø2.5; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-; LARGE QUICK COUPLING; RATCHET WRENCH-11MM WIDTH ACROSS FLATS; RATCHTNG HANDL W QUICK CUPLING; SM FRG LCP INST & IMPL SET GRPIC CASE; SOCKET WRENCH-11MM WIDTH ACROSS FLATS; UNIVERSAL CHUCK WITH T-HANDLE; UNIVERSAL CHUCK WITH T-HANDLE