MAUDE Adverse Event Report: SYNTHES GMBH CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 03.010.404

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 09/25/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2022, during a tibial nail surgery, the surgeon was attempting to disassemble the connecting screw from the nail following implantation.The connecting screw had seized and appeared to be cross threaded.The surgeon struggled mightily to undo the connecting screw and was finally able to get it undone.Upon close examination, the connecting screw was deemed to be no longer functional and it was subsequently discarded.There were no patient consequences.There was a delay in surgery of approximately one minute in relation to the reported event.No further information is available.This report involves one cann connecting scr f/percutan instruments for nails-ex.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.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: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• 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: 15614982
• MDR Text Key: 306714078
• Report Number: 8030965-2022-08239
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819501706
• UDI-Public: 07611819501706
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK - NAILS: TIBIAL.