MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS DEPTH GAUGE FOR 2.7 SCREWS; FORCEPS

Model Number 03.118.007

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

It was reported that on an unknown date, in the sterile processing department (spd) it was noticed, that the tip depth gauge was bent.There was no patient involvement.This complaint involves one (1) device percutaneous depth gauge for 2.7 screws.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.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.

• Brand Name: PERCUTANEOUS DEPTH GAUGE FOR 2.7 SCREWS
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13577926
• MDR Text Key: 288303790
• Report Number: 2939274-2022-00590
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982073365
• UDI-Public: (01)10886982073365
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: 03.118.007
• Device Catalogue Number: 03.118.007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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