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 Codes	Device Operates Differently Than Expected (2913); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information not available for reporting.Device malfunctioned intra-operatively unknown if it was implanted / explanted.No material will be available, device is not expected to be returned for manufacturer review/investigation.(b)(6).Additional 510k's: k033158 - k031428.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the large open pen adj-clamo mr-conditional was unable to hold on firmly.This is all information that have been obtained.Complaint involves one part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Corrected data: date of event is unknown.Additional narrative: a device history record review was performed for the subject device: article 390.008 with lot 7108369 manufactured in the us.Brw dhr review: mfg part no: 390.008, lot no: 7108369, mfg site: (b)(4), release to warehouse date: 05-dec-2012, supplier dhr: n/a.No ncrs were generated during production.Review of the device history: record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation is possible.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.

• 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: 7266730
• Report Number: 8030965-2018-51056
• Device Sequence Number: 11219352
• Product Code: KTT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592(10)7108369
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 7108369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1