MAUDE Adverse Event Report: SYNTHES GMBH CONNECTING SCREW/ CANNULATED LONG; SCREW, FIXATION, BONE

Model Number 03.043.025

Device Problems Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 11/01/2022

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.Additional product code: jds.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.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 on (b)(6) 2022, that the connecting bolt was causing issue; it was possibly bent, but when used, the nail wasn't tightly secured as with the other connecting bolt.Screws were placed free hand and surgery completed.Missed screw removed and screws were placed free hand.There was a surgical delay of 20 minutes.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unk - nails: tibial (part# unknown; lot# unknown; quantity: 1).Unk - screws: trauma (part# unknown; lot# unknown; quantity# unknown).Unk - nail insertion handles (part# unknown; lot# unknown; quantity: 1).This report is for one (1) connecting screw/ cannulated long.This is report 1 of 1 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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.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

After checking the device, the surgeon thought it was best if the aiming arm were replaced as well.Device may be causing the aiming arm to misalign with the nail causing screws to miss.This is report 1 of 2 for (b)(4).

• Brand Name: CONNECTING SCREW/ CANNULATED LONG
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15874716
• MDR Text Key: 307740226
• Report Number: 8030965-2022-10317
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982297242
• UDI-Public: (01)10886982297242
• 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: Physician
• Type of Report: Initial,Followup,Followup

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: 03.043.025
• Device Catalogue Number: 03.043.025
• Device Lot Number: 295P547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/30/2022; 01/30/2023
• Supplement Dates FDA Received: 12/30/2022; 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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: AIM-ARM RADIOLUC; UNK - NAIL INSERTION HANDLES; UNK - NAILS: TIBIAL; UNK - SCREWS: TRAUMA