MAUDE Adverse Event Report: SYNTHES GMBH SMALL HEXAGONAL PELVIC SCREWDRIVER/LARGE HANDLE; SCREWDRIVERS

Model Number	SD314.001
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 conclusion could be drawn at the time of filing this report.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 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) 2021, the patient underwent an unknown surgical procedure for an unknown reason.The surgeon was inserting a 3.5mm cortical screw with a small hexagonal pelvic screwdriver.After the screw was inserted into the bone, the driver would not disengage.The surgeon was able to remove the screwdriver by using a mallet to knock the driver back and in the process, the handle broke apart from the 2.5 hex shaft.Mallet driver out followed by using another hex driver instrument.Fragments were generated.The procedure was completed successfully with a surgical delay of five (5) minutes.There was no patient consequence.Concomitant device reported: unknown mallet (product# unknown, lot# unknown, qty unknown).This complaint involves two (2) devices.This report is for (1) small hexagonal pelvic screwdriver/large handle.This report is 1 of 2 (b)(4).

• Brand Name: SMALL HEXAGONAL PELVIC SCREWDRIVER/LARGE HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11737826
• Report Number: 8030965-2021-03366
• Device Sequence Number: 4168275
• Product Code: HXX
• UDI-Device Identifier: 10886982004567
• UDI-Public: (01)10886982004567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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 Model Number: SD314.001
• Device Catalogue Number: SD314.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1