MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Model Number 319.004

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j employee.Investigation summary: background: it was reported that on an unknown date, during routine incoming inspection of a loaner set, the depth gauge for 1.3mm and 1.5mm screws was missing a piece.There was no patient and surgical involvement.This complaint involves one device.Device history lot: part number:319.004, synthes lot number: h694162, supplier lot number: n/a, release to warehouse date: 17oct2009, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history batch null, device history review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: depth gauge for 1.3mm and 1.5mm screws (part# 319.004, lot# h694162, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the needle of the depth gauge got slightly deformed.It is also observed that the protection sleeve component was missing from the assembly.The rest of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Device failure/ defect was found.Dimensional inspection (calipers: (b)(4)): dimensional inspection of the received device was performed at cq.The diameter of the needle was measured and was within specification.Documentation/ specification review: the following drawing(s) was reviewed.Depth gauge for 1.3/ 1.5 screws: 319_004 rev.F and rev.P.Protection sleeve: 319_006_1 rev.C and rev.E.Needle: 319_004_3 rev.F.No design issues or discrepancies were found during this investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for depth gauge for 1.3mm and 1.5mm screws (part# 319.004, lot# h694162) as the assembly is missing protection sleeve component.While a definitive root cause could not be determined for the reported problem, it is highly possible that the component might have got misplaced during sterilization.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.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 routine incoming inspection of a loaner set, the depth gauge for 1.3mm and 1.5mm screws was missing a piece.There was no patient and surgical involvement.Concomitant device reported: depth gauge for 1.3mm and 1.5mm screws, (lot #h299833 & qty unknown).This complaint involves one device.This report is for one depth gauge for 1.3mm and 1.5mm screws this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: g4 provided for reporting.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.G4.

• Brand Name: DEPTH GAUGE FOR 1.3MM AND 1.5MM 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: 11229404
• MDR Text Key: 239090281
• Report Number: 2939274-2021-00468
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.004
• Device Catalogue Number: 319.004
• Device Lot Number: H694162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 01/28/2021
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS.