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 Problem Device-Device Incompatibility (2919)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Part # 319.006, synthes lot # 4569369, supplier lot # n/a, release to warehouse date: 18 mar2003, manufactured by: synthes (b)(4).No 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 f/scr ø2+2.4 meas-range up-t (p/n: 319.006, lot #: 4569369) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the needle component of the device was slightly bent.Also, the protection sleeve was not returned.Some light scratches were observed on the device surface, which could not impact the device functionality.No other issues were observed with the complaint device.Functional test: a functional test was performed.The needle component of the device didn't slide smoothly inside the body component of the device, it showed resistance.The bent condition of the needle component could have contributed to the device interaction issue.Can the complaint be replicated with the returned device(s)? yes.Dimensional inspection: measured dimensions: needle diameter = conforming.Document/specification review.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Depth gauge for 2.0/ 2.4mm screws.Needle.Protection sleeve.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the needle component is bent and didn't slide smoothly inside the body component of the device.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 for the bent needle could be due to unintended forces applied to the device and the potential cause for device interaction could be due to the bent condition of the needle.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 unknown date the patient underwent a unknown procedure.It was noted that two products were affected during procedure.The depth gauge was not sliding well.In the second portion, the surgeon had inserted a 2.4 va locking screw into the styloid of the distal radius plate.The screw did not lock into the plate and was just spinning.The surgeon chose a shorter screw to see if it would lock and it also did not lock into the plate.The surgeon ultimately removed the screw and placed a locking screw into a different hole.The surgery was completed successfully.There was a five minutes of surgical delay noted.No patient consequences noted.Concomitant device: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 2 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: 12561511
• MDR Text Key: 274250617
• Report Number: 2939274-2021-05864
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819707238
• UDI-Public: 07611819707238
• 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: Physician
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 4569369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2003
• 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: UNKNOWN SCREWS.; VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H.
• Patient Age: 59 YR
• Patient Weight: 74