MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE, DEPTH

Model Number 03.010.072

Device Problem Use of Device Problem (1670)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.Visual inspection: the depth gauge f/lock-scr meas-range-110 f/ (p/n: ,03.010.072, lot #: 9253475) was returned and received for analysis.Upon visual inspection, the ball and spring assembly is missing, confirming the reported condition.Additionally, the tip of the device appears to be slightly deformed.No other issues were observed with the returned device.Dimensional inspection: a dimensional inspection was not performed due to the definitive finding of a missing component and post manufacturing damage.Document/specification review: relevant documents were reviewed.Investigation conclusion: the reported condition of the complaint device (depth gauge f/lock-scr meas-range-110 f/) is confirmed.Ball and spring assembly is missing in the device.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.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.A device history record (dhr) review was conducted: part:03.010.072, lot: 9253475, manufacturing site: (b)(4), release to warehouse date: 27 jan 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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) 2021, during a procedure while putting trays together, it was noted that a depth gauge is missing a stopper on slide.Surgeon noted it was not in the patient.There was no surgical delay and the procedure was successfully completed.Patient status is unknown.During manufacturer's investigation of the returned device it was also identified that the tip of the device appears to be slightly deformed.This device condition was evaluated and determined to be reportable on (b)(6) 2022.This report is for one (1) depth gauge for locking screws to 100mm for im nails.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• 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: 13394401
• MDR Text Key: 284702143
• Report Number: 2939274-2022-00295
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: (01)10886982067449
• 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: Health Professional,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: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: 9253475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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: 90 YR
• Patient Sex: Female