MAUDE Adverse Event Report: SYNTHES GMBH DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM

Catalog Number 03.019.029

Device Problems Incorrect Measurement (1383); Illegible Information (4050)

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

Event Date 08/04/2023

Event Type  malfunction  

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.E1 initial reporter facility name: (b)(6).E3: reporter is a j&j employee.H3, h4, h6: part # 03.019.029 lot # 3l18345 manufacturing site: werk hagendorf release to warehouse date: 14 feb 2019 supplier: n/a expiration date: n/a a manufacturing record evaluation was performed for the finished article lot 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 device found that the needle of the length probe f/multiloc hum nail syst was bent from the wire measuring head the problems for measurement are most probably caused due to this condition.The etch of the device is visible sings of faded or smeared were not observed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection for the length probe f/multiloc hum nail syst was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the length probe f/multiloc hum nail syst would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery.During surgery, the scale on the tip of the depth gauge was unreadable.The scale for screw-in-screw measurement was almost lost, and the exact value could not be read.The surgery was completed successfully with no surgical delay.The patient was reported as stable.This report involves one (1) depth probe for multiloc humeral nailing system.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM
• Type of Device: PROBE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 18246082
• MDR Text Key: 329480951
• Report Number: 8030965-2023-15147
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 07611819462311
• UDI-Public: 07611819462311
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.029
• Device Lot Number: 3L18345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• 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