MAUDE Adverse Event Report: SYNTHES GMBH CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.404
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
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, while doing an expert tibial nail with supra-patellar approach, after finishing of inserting the screws the surgeon wanted to remove the handle to start closing.The handle was stuck and the surgeon tried to disassemble the connecting screws (between the handle and the nail) with no result.So surgeon eventually removed the screws and took the nail totally out of the patient and tried to disassemble it outside and it worked.Then surgeon asked to open another nail (with same diameter and length) and inserted new nail and the screws.After finishing the screws he was able to remove the handle normally.The surgery was delayed for twenty five (25) minutes due to the reported event.The procedure was successfully completed with no other medical intervention required.This report is for one (1) cann connecting scr f/percutan instruments for nails-ex this is report 1 of 4 for complaint (b)(4).

• Brand Name: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12379841
• Report Number: 8030965-2021-07316
• Device Sequence Number: 19935231
• Product Code: FZX
• UDI-Device Identifier: 07611819501706
• UDI-Public: (01)07611819501706
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 08/01/2021

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: 03.010.404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCRDRIVER-HEX W/SPHERIC-HEAD Ø8; UNK - NAIL INSERTION HANDLES: RADIOLUCENT; UNK - NAILS: EXPERT TIBIAL