MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE,DEPTH

Catalog Number 03.019.017

Device Problem Material Deformation (2976)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j representative. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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, the patient underwent for a procedure. The impactor was coming apart during surgery and the depth gauge was bent, there was no surgical delay. The surgery was completed successfully. The patient outcome was unknown. This complaint involves (2) devices. This report is for (1) depth gauge for multiloc humeral nailing system. This report is 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
• 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13078893
• MDR Text Key: 283671047
• Report Number: 2939274-2021-07215
• Device Sequence Number: 1
• Product Code: HTJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.019.017
• Device Lot Number: 65P5484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/23/2021 Patient Sequence Number: 1

Treatment

DRIVING CAP