MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR CANN MED; NAIL, FIXATION, BONE

Catalog Number	03.043.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an orif with tna for the tibial diaphyseal fracture.This case was deployed with a lateral parapatellar approach.After checking outside of the body, the nail was inserted with hammering.When drilling to insert a screw into the proximal static ml hole, the drill bit interfered with the nail.The surgeon decided that slight adjustment was necessary, and drilled to the proximal dynamic ml hole.However, the drill bit interfered with the nail again.Since the aiming arm was not working properly, drilling was proceeded manually, and the screw was inserted.When the connecting screw was removed, there was a strange sound.No further information is available.This report involves connecting screw/ cannulated medium.This is report 5 of 5 for (b)(4).
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6: product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONNECSCR CANN MED
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20189076
• Report Number: 8030965-2024-11141
• Device Sequence Number: 15218429
• Product Code: JDS
• UDI-Device Identifier: 07612334171030
• UDI-Public: (01)07612334171030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 03.043.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM RADIOLUC.; DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC.; INSERT-HANDLE RADIOLUC MED.; TIBIAL NAIL ADVANCED Ø9 L 270.
• Patient Sex: Unknown