MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø6 L72 F/NAILS TAN AQUA; SCREW, FIXATION, BONE

Catalog Number 04.005.662

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

During removal of screw, three screws were broken.So the surgeon couldn't remove them.This complaint involves three (3) devices.This report is for one (1) lockscr ø6 l72 f/nails tan aqua.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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 narrative: reporter is a j&j employee.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.

• Brand Name: LOCKSCR Ø6 L72 F/NAILS TAN AQUA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16234433
• MDR Text Key: 308855760
• Report Number: 8030965-2023-00857
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819779129
• UDI-Public: (01)07611819779129
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K970733
• 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
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø6 L72 F/NAILS TAN AQUA; LOCKSCR Ø6 L72 F/NAILS TAN AQUA