MAUDE Adverse Event Report: SYNTHES GMBH IMPACTOR F/PFNA BLADE

Catalog Number 356.823

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983); Noise, Audible (3273)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2024, during a surgery, the blade was attached to the inserter as usual, and it was verified that the lock of the blade was released and rotate freely.The surgeon inserted the blade by hammering according to the surgical technique.The surgeon turned the inserter to the ¿locked¿ direction and released the connection between the inserter and blade, but the connection was stiff, and the surgeon could not turn the insertion.The surgeon continued turning the insertion, but a grating sound was heard, and it seemed idled.The surgeon turned the insertion to the opposite direction, but the same condition occurred.When looking at the image intensifier in a situation where the insertion handle was turned to the maximum locked state, there was still a gap in the extending and retracting part, and the state seemed between ¿attached¿ and ¿locked¿.Since the insertion handle could not be turned any further in the ¿locked¿ direction, the surgeon removed the blade by hammering.The procedure was done by using another inserter and blade.The surgery was completed successfully with no surgical delay.After the surgery, the inserter and blade were attempted to detach by grasping the blade with a tool like pliers, but a grating sound was heard, and the inserter and blade were in a state of being stuck and turning.The blade could not be released although the inserter was managed to be turned to the ¿locked¿ state.Patient outcome is reported as stable.No further information is available.This report is for one (1) impactor f/pfna blade this is report 3 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H11 additional narrative: d9: device returned.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H4: manufacture date added.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: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19176238
• MDR Text Key: 341585673
• Report Number: 8030965-2024-05386
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819291317
• UDI-Public: (01)07611819291317
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2199603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2006
• 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: PFNA-II BLADE L90 TAN; PFNA-II BLADE L90 TAN