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

Model Number 319.006

Device Problem Material Discolored (1170)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 319.006, synthes lot: 6188417, supplier lot: na, release to warehouse date: july 30, 2009, manufactured by synthes (b)(4).No nonconformance reports (ncrs) 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.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws was received at us customer quality (cq).Upon visual inspection, the needle was bent and the device was found to have surface scratches and minor discoloration.Dimensional inspection: measured dimensions: needle shaft od: conforming.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the visual inspection of the complaint device revealed bent needle, surface scratches and discoloration.No definitive root cause could be determined based on the provided information.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 preventive 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 during inspection of back up items on unknown date, some were set aside for expired exchange.One (1) bending pliers have no tension.Two (2) topcoat from the depth gauges are peeling.One (1) handle with quick coupling gets stuck.One (1) universal drill guide has pitting on the handle.One (1) stardrive screwdriver is losing its shape.And two (2) socket wrenches have pitting on the swivel.There was no patient involvement.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 2 of 3 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11792057
• MDR Text Key: 249542731
• Report Number: 2939274-2021-02262
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: 6188417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2009
• 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: 2.0MM UNIVERSAL DRILL GUIDE; 2.4/2.7MM VA-LCP BENDING PLIER; HANDLE WITH QUICK COUPLING, SMALL; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SOCKET WRENCH-11MM WIDTH ACROSS FLATS