MAUDE Adverse Event Report: SYNTHES GMBH NAIL EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	03.037.032
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional 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 narrative: additional product code: hsb 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.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 or Problem Description
It was reported that on (b)(6) 2023, the surgeon removed a tfna nail and revised with another tfna nail.The surgeon had difficulties connecting the nail extractor likely due to the set screw being too far back, too much soft tissue inside of nail, blocked by other structures from being collinear to allow extractor to connect.The surgeon connected the aiming arm for extraction and it was successfully removed.The extractor was checked post operatively and it did successfully connect to the nail, therefore, it was likely blocked by other structures.Currently, there is no plan to return the extractor unless needed.There was a surgical delay of 5 min.The procedure was completed successfully and there were patient consequences/outcomes.This report is for one (1)nail extractor this is report 3 of 3 for complaint (b)(4).

• Brand Name: NAIL EXTRACTOR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 16736783
• Report Number: 8030965-2023-04598
• Device Sequence Number: 6663738
• Product Code: HSB
• UDI-Device Identifier: 10886982070487
• UDI-Public: (01)10886982070487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 03.037.032
• Device Catalogue Number: 03.037.032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/130 DEG TI CANN TFNA 360/LEFT - SILE; TFNA FENESTRATED SCREW 95MM; UNK - SCREWS: LOCKING
• Patient Age: 46 YR
• Patient Sex: Male