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

Model Number 319.01

Device Problem Material Deformation (2976)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device was received, the investigation is in progress, 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) 2021, patient underwent an unknown surgical procedure.During the procedure, the depth gauge was not sliding well, and it was noticed that a portion of it had possibly been bent.In addition to the depth gauge, a 2.0mm drill bit was bent while drilling a hole and wrapped up some soft tissue.The surgeon bent the drill bit while moving the drill around while drill bit was in bone.Another depth gauge and drill bit were grabbed, and the surgery was successfully completed.There was no surgical delay and there was no patient consequence.This complaint involves two (2) devices.This report is for (1) depth gauge for 2.7mm & small screws.This report is 1 of 1 for (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.H3, h6: a product investigation was conducted.Service & repair evaluation: the customer reported the depth gauge was not sliding well and possibly bent.The repair technician reported the device operation was found to be smooth and non-binding.Lube/oil/clean is the reason for repair.The cause of the issue is unknown.The item was repaired per the inspection sheet, passed synthes final inspection on 26-jul-2021 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.H3, h6: a device history record (dhr) review was conducted: part: 319.01, lot: 7929712, manufacturing site: hagendorf, release to warehouse date: 12 june 2012, a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 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
• MDR Report Key: 12178092
• MDR Text Key: 261934656
• Report Number: 2939274-2021-04131
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: 7929712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Patient Age: 21 YR
• Patient Weight: 86