MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: NAIL PROXIMAL LOCKING; SCREW, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

Device report from synthese reports an event in the netherlands as follows: the site roe (rotterdam, netherlands) reported an adverse event which is considered (possibly) related to the device.It was reported that the patient underwent surgery to implant the nail on (b)(6) 2022.On (b)(6) 2023, the patient experienced secondary loss of reduction.Revision surgery occurred on (b)(6) 2023 for exploration of proximal loose fragment and reposition and refixation.This report involves one unk - screws: nail proximal locking.This is report 2 of 7 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.This report is for an unknown screws: nail proximal locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: UNK - SCREWS: NAIL PROXIMAL LOCKING
• 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16437281
• MDR Text Key: 310172383
• Report Number: 8030965-2023-02308
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2023
• 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: EXPERT TN Ø12 CANN L375 TAN LIGHT GREEN; UNK - END CAPS: TIBIAL NAIL; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG