MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS; GAUGE, DEPTH

Model Number 03.111.005

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 an unknown date, during inspection of the back up devices it was discovered that the gold peg of one (1) recon locking aiming arm for lfn nails-ex has snapped off, the threads of one (1) extraction screw for ti femoral & tibial nails and one (1) extraction screw/m8 for suprapatellar are stripped, and one (1) depth gauge for 2.0/2.4 and 2.7 screws was stuck in place.There was no patient involvement.This report is for one (1) depth gauge for 2.0mm/2.4mm and 2.7mm screws.This is report 4 of 4 for complaint (b)(4).

Event Description

This is report 4 of 6 for pc-(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part: 03.111.005 lot: 3740500 manufacturing site: hagendorf supplier: n/a release to warehouse date: august 25, 2011 expiration date: n/a a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the depth gauge for 2.0/2.4 and 2.7 screws was found to have the needle deformed.Functional issues are most likely due to this condition.A dimensional inspection for the depth gauge for 2.0/2.4 and 2.7 screws was unable to be performed due to post manufacturing damage.A functional test was performed by advancing and retracting the slider, movement was completed partially as the needle is deformed.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the depth gauge for 2.0/2.4 and 2.7 screws would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.*********************************************** drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: - depth gauge for screws 2.0/2.4/2.7 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.B5 d9.

• Brand Name: DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14001650
• MDR Text Key: 290468348
• Report Number: 2939274-2022-01190
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072078
• UDI-Public: (01)10886982072078
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.111.005
• Device Catalogue Number: 03.111.005
• Device Lot Number: 3740500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; EXTRACTION SCR FOR TI FEM & TIB NAIL; EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; REAMING ROD PUSH ROD WITH BALL HANDLE; RECON LCKNG AIMING ARM FOR LFN NAILS-EX; SMALL UNIVERSAL CHUCK WITH T-HANDLE; WIRE CUTTER 220MM