MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM; NAIL, FIXATION, BONE

Catalog Number	03.010.485
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, during an unknown procedure, when drilling through the oblique holes on the aiming arm, the drill did not align and hit the nail.The surgeon had to remove the drill sleeve and drill through outer protection sleeve.No further information was provided.This is report 1 of 6 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.Device history lot part number: 03.010.485 lot number: 9590916 part/lot combination is unknown at jabil (in epr sap p02), no dhr review possible for group "synthes trauma - mfg - dhr - hagendorf".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: RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13713306
• Report Number: 8030965-2022-01476
• Device Sequence Number: 5434412
• Product Code: JDS
• UDI-Device Identifier: 07611819498846
• UDI-Public: (01)07611819498846
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040762
• 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

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: 03.010.485
• Device Lot Number: 9590916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/09/2022
• 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: INSERT-HANDLE RADIOLUC F/ETN; UNK - DRILL; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAILS
• Patient Sex: Unknown