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

Catalog Number 319.006

Device Problems Component Missing (2306); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a j&j employee.A product investigation was conducted.Visual inspection: the depth gauge for 2.0 mm and 2.4 mm screws (part #: 319.006, lot #: 5682849) was received at us cq.Upon visual inspection, it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base.No other issues were identified.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage and device geometry.Document/specification review: the relevant drawing(s) were reviewed: no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the complaint device was missing the protection sleeve component and the tip of the device was bent at the proximal base.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use and/or the missing components of the device were displaced when taken apart for sterilization.No new, unique or different patient harms were identified as a result of this evaluation.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 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.A device history record (dhr) review was conducted: part # 319.006, synthes lot # 5682849, supplier lot # n/a, release to warehouse date: 18 jan 2008, manufactured by synthes (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.

Event Description

It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge was missing a piece.There was no known patient or hospital involvement.During manufacturer's investigation of the returned device it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base.This product condition was re-evaluated and found to be reportable on (b)(6) 2020.This report is for one (1) depth gauge for 2.0 mm and 2.4 mm screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10550648
• MDR Text Key: 208010131
• Report Number: 2939274-2020-04189
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 1088698218994
• UDI-Public: (01)1088698218994
• 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
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 5682849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2008
• 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