MAUDE Adverse Event Report: SYNTHES GMBH CYLINDER FOR INSERTION INSTRUMENTS; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	03.168.015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a revision surgery due to pain.Originally, the patient underwent for a surgery with fns implants on (b)(6) 2021.On (b)(6) 2021, the patient was reported pain and scheduled for revision surgery.In the revision, after the anti-rotation screw was removed, when the surgeon tried to remove the locking screw with an extraction screwdriver, the screwdriver broke, and the fragment was remained in the screw head.The revision surgery was completed successfully within 30minutes delay.No further information is available.Concomitant device reported.Carbide drill bit ¿4 f/instr (part# 309.004s, lot# unknown, quantity# 1), diamond bar (part# 309.004s, lot# unknown, quantity# 1), sparecenterpin f/309.065 (part# 309.670, lot# unknown, quantity# 1), unk - nail head elements: fns bolt (part# unknown, lot# unknown, qty1), unknown unk - nail head elements: fns antirotation (part# unknown, lot# unknown, qty1).This complaint involves four (4) devices.This report is for (1) cylinder for insertion instruments.This report is 4 of 4 for (b)(4).Related product complaint: (b)(4).

• Brand Name: CYLINDER FOR INSERTION INSTRUMENTS
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12288963
• Report Number: 8030965-2021-06479
• Device Sequence Number: 3807357
• Product Code: GEA
• UDI-Device Identifier: 07611819657410
• UDI-Public: (01)07611819657410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 03.168.015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARBIDE DRILL BIT Ø4 F/INSTR STEEL+TI; DIAMOND BAR; MULTIFUNCTION ROD F/INSERTION INSTR; SPARECENTERPIN F/309.065; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - PLATES: FNS; UNK - SCREWDRIVERS; UNK - SCREWS: FNS LOCKING