MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER T40 W/SPHERIC-HEAD CANN L277; SCREWDRIVER

Catalog Number	03.010.520
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Product was not returned.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.
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 the osteosynthesis surgery for the femoral trochanteric fracture with the screwdriver in question.The surgeon used the screwdriver to insert the endcap, but the endcap couldn¿t be inserted.Procedure was completed successfully with fifteen(15) minutes delay.Concomitant device reported: unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1)cannulated stardrive screwdriver/t40/277mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: SCRDRIVER T40 W/SPHERIC-HEAD CANN L277
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12675309
• Report Number: 8030965-2021-08867
• Device Sequence Number: 13760925
• Product Code: HXX
• UDI-Device Identifier: 07611819499164
• UDI-Public: (01)07611819499164
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 03.010.520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1