MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE/ RADIOLUCENT LONG; SCREW, FIXATION, BONE

Model Number 03.043.024

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/03/2023

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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2023, drill bit was hitting the nail (distal, transverse hole) while using the aiming arm for proximal screws.Faulty targeting, which involves the insertion handle, aiming arm, connecting screw, and trocars.Procedure was completed successfully with 15 minutes surgical delay.No patient was harmed.This report is for one (1) insertion handle/radiolucent long.This is report 3 of 10 for complaint (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.Additional narrative: h4 device history: part number: 03.043.024, lot number: 364p539, manufacturing site: haegendorf, release to warehouse date: 18.01.2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.A product non-conformance jbl-nr-0012201 was opened for the finished device lot number, however, this nc is not related to the device not moving, but to the inspection of ctq feature for component 60112455 being correctly cascaded to inspection plans.This component 60112455 is used for the mounting of the carbon part with steel part of the insertion handle 03.043.024.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: INSERTION HANDLE/ RADIOLUCENT LONG
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16436218
• MDR Text Key: 310288736
• Report Number: 8030965-2023-02281
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982297235
• UDI-Public: (01)10886982297235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201336
• 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: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.043.024
• Device Catalogue Number: 03.043.024
• Device Lot Number: 364P539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: AIMING ARM/ RADIOLUCENT.; AIMING ARM/ RADIOLUCENT.; CONNECTING SCREW/ CANNULATED LONG.; CONNECTING SCREW/ CANNULATED LONG.; DRILL SLEEVE / 4.2MM.; DRILL SLEEVE / 4.2MM.; INSERTION HANDLE/ RADIOLUCENT LONG.; PROTECTION SLEEVE/ 11/8.; PROTECTION SLEEVE/ 11/8.