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 Device-Device Incompatibility (2919)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, during a procedure, the surgeon complained that the small fragment depth gauge did not fit into the screw holes like in the 2.7 hole of a wrist fusion plate like the 3.5 holes.The surgeon was concerned that screws would be measured wrong.This complaint was non specific to a specific depth gauge; just the small fragment depth gauge in general since a couple of different ones were used.Therefore, there is nothing wrong with the depth gauge and it will not be returned.The surgeon removed 2mm from the measurement as a precaution.The surgery was completed successfully.This report involves one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: part: 319.010 lot: l961176 manufacturing site: hägendorf release to warehouse date: 18 oct 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that depth gauge f/scr ø2.7-4 meas-range up-t, it was observed that the needle component of the device was bent from the tip.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.A dimensional inspection for the depth gauge f/scr ø2.7-4 meas-range up-t was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to mating device was not received (screw).The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the depth gauge f/scr ø2.7-4 meas-range up-t would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14514091
• MDR Text Key: 297523499
• Report Number: 2939274-2022-01931
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• 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: 319.010-US
• Device Lot Number: L961176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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: LCP WRIST FUSION SHORT BEND PLATE
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 89 KG