MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERTION SHIELD FOR TRAUMA RECON SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.203
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported from (b)(6) that during an unspecified surgical procedure of the knee, it was observed that the battery cover (carrier) insertion shield device was broken.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: INSERTION SHIELD FOR TRAUMA RECON SYSTEM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7277907
• Report Number: 8030965-2018-51193
• Device Sequence Number: 2300788
• Product Code: HWE
• UDI-Device Identifier: 10886982129659
• UDI-Public: (01)10886982129659(11)151007
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/24/2018

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: 05.001.203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1