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 Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Part: 319.010, lot: 3617519, manufacturing site: (b)(4), release to warehouse date: 22 november 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: upon inspection, the needle shaft was found bent/deformed at the middle and at distal part.There was a nick mark at the middle of the needle shaft.It is bend in the distal portion of the hook.Under magnification, it was observed that the small piece of the hook is sheared/broken off.The broken off piece was not received.It is possible that the device would not be functioning as intended or would not provide accurate measurement as distal end would not engage properly due to bending and broken condition of the hook.Hence the complaint is confirmed.Service & repair evaluation: the customer reported the hook on the depth gauge was worn not allowing the surgeon to "hook" the far cortex to get an accurate measurement.The repair technician reported the tip is damaged.Broken tip is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: the appropriate height of the hook can not be measured due to broken condition.The diameter of the needle shaft at distal end is measured 1.10 mm which is with in specification of 1.2+0/-0.1 mm per drawing.Conclusion: the complaint is confirmed.No definitive root cause could be determined however, it is likely that the device experienced excessive force during uses.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.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) 2019, during the fixation of the fibula the hook on the depth gauge was worn out not allowing the surgeon to hook the far cortex to get an accurate measurement.The surgeon used a backup one peel packed to complete the surgery.There was a surgical delay of two (2) minutes and the surgery was completed successfully.The patient outcome was good.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9396777
• MDR Text Key: 194841659
• Report Number: 2939274-2019-62423
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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: 3617519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• 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
• Patient Age: 18 YR
• Patient Weight: 50