MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME TUBE-TO-TUBE CLAMP; LAMP, OPERATING ROOM

Model Number	387.353
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 all parts of a spine kit that need to be tightened or locked need to be lubricated.This was noted during an anterior lumbar interbody fusion (alif) case on (b)(6) 2020 where there were device interaction issues.Additionally, 2 blue clamps have been tagged because they were not gripping to the o-ring properly.Concomitant device reported: unknown o-ring (part # unknown, lot # unknown, quantity unknown).This is report 5 of 10 for (b)(4).This complaint is linked to (b)(4).

• Brand Name: SYNFRAME TUBE-TO-TUBE CLAMP
• Common Device Name: LAMP, OPERATING ROOM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10380428
• Report Number: 8030965-2020-05755
• Device Sequence Number: 16575515
• Product Code: FQP
• UDI-Device Identifier: 10705034771144
• UDI-Public: (01)10705034771144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K993314
• 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): 07/19/2020

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 Model Number: 387.353
• Device Catalogue Number: 387.353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1