MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Catalog Number	390.008
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: lxt.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an unknown date, the screw of the self-holding clamp was loosen and the nut was unmovable.It is unknown how the issue was discovered.There was no patient and surgical involvement.This report is for one (1) large ex-fix open adj clamp mr-conditional.This is report 1 of 1 for complaint (b)(4).

• Brand Name: LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8500791
• Report Number: 8030965-2019-62673
• Device Sequence Number: 11435345
• Product Code: KTT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 390.008
• Device Lot Number: 1531623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1