MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM CARBON FIBER ROD 75MM; BONE PLATE

Catalog Number	395.111
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional device product code: ktt.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the holding clamp for the external fixator did not match the carbon fiber rod diameter during an unknown orthopedic procedure on an unknown date.It was unknown if there was a surgical delay.Patient outcome is unknown.This report is for one (1) 3.0mm carbon fiber rod 75mm.(b)(4).

• Brand Name: 3.0MM CARBON FIBER ROD 75MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7701055
• Report Number: 8030965-2018-55157
• Device Sequence Number: 11167434
• Product Code: JEY
• UDI-Device Identifier: 07611819200050
• UDI-Public: (01)07611819200050
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 395.111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1