MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER HANDLE UNIV; SCREWDRIVERS

Catalog Number	03.133.150
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of proximal end of tibia.For tibial plateau fracture, the surgeon tried to fix with a medial proximal tibia plate from posterior side.Because the operative field was deep and narrow, the sales rep instructed the surgeon to perform the procedures according to the usf surgical technique and catalog.Surgery was performed according to that surgical technique and completed within 30 minutes delay.Based on the event "another surgeon noticed this, reattached the threaded guide properly again, and fixed the plate.No further information is available.This complaint involves four (4) devices.This report is for one (1) screwdriver handle univ.This report is 2 of 4 for (b)(4).

• Brand Name: SCREWDRIVER HANDLE UNIV
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12037625
• Report Number: 8030965-2021-05153
• Device Sequence Number: 3975653
• Product Code: HXX
• UDI-Device Identifier: 07612334122162
• UDI-Public: (01)07612334122162
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 03.133.150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1