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 Device-Device Incompatibility (2919)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: the depth gauge for 1.3mm and 1.5 mm screws (p/n: 319.004, lot #: 4206824 was returned and received.Upon visual inspection, it was observed that the distal tip of the needle component was bent and deformed.Additionally, slight scratches were observed on the device.No other issues were identified with the returned device.The sliding bar does not slide smoothly because of the deformity of the tip, it might also cause not to fit on the 1.1mm drill hole.Can the complaint condition be replicated? no, the complaint condition cannot be replicated during functional test.Dimensional inspection was not performed due post manufacturing damage.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The reported condition of the complaint device (depth gauge for 1.3mm and 1.5mm screws) is confirmed.The distal tip of the needle component was bent and deformed causing struggle to slide.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device and the potential cause for missing protection sleeve could be due to device incorrectly assembled during the sterilization process.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 history lot -no ncrs were generated during production.Device history review - 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.If information is obtained a follow-up medwatch will be filal medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, a patient underwent an open reduction and internal fixation metacarpal procedure.During the procedure the depth gauge would not fit through 1.1mm drill hole.A mini fragment set was pulled to complete the procedure with a different style depth gauge.The procedure was completed successfully with a surgical delay of five (5) minutes.This report is for one (1) depth gauge for 1.3mm and 1.5mm screws.This is report 2 of 2 for complaint (b)(4).

• 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
• 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: 13142156
• MDR Text Key: 285644762
• Report Number: 2939274-2022-00001
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• 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: 4206824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2000
• 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: UNK - PLATES: MODULAR HAND SYSTEM; UNK - SCREWS: HAND; UNKNOWN - DRILL GUIDES