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 Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is company representative.Investigation summary: 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: the depth gauge for 2.0 mm and 2.4 mm screws (p/n 319.006 lot 4872211) was received with the needle component broken off from the slider.The transverse fracture was located at the interface between the needle and slider.No other issues were identified.Dimensional inspection: feature: needle shaft diameter.Specification: 1.25 mm + 0/-0.05 mm.Measured dimension: 1.22 mm.Result: conforming.Measurement device: caliper ca215p.Document/specification review: drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the depth gauge for 2.0 mm and 2.4 mm screws (p/n 319.006 lot 4872211) as the needle component was broken off from the slider.No definitive root cause could be determined.It is possible that the broken condition was due to excessive/unintended forces and/or consistent use/reprocessing over the part¿s lifetime caused the needle to become loose and eventually break off.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

Event Description

It was reported on (b)(6) 2019, during a routine inspection of a loaner set-modular hand system- at (b)(4) metro office, the depth gauge broke apart.The thin metal tip broke away from the handle/sizing guide when removing the gauge from the outer sleeve.No other incident was reported relative to this occurrence.There was no patient involvement.This complaint involves one (1) device.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: 9109655
• MDR Text Key: 159795345
• Report Number: 2939274-2019-60830
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: 4872211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/24/2019
• Date Device Manufactured: 10/14/2004
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1