MAUDE Adverse Event Report: SYNTHES GMBH SYNFRAME INSULATED TABLE CLAMP; MISC ORTHO SURGICAL INSTR

Model Number	387.346
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation is in progress.Device history lot: part: 387.346.Lot: bag0957.Manufacturing site: (b)(4).Release to warehouse date: aug.30, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, while the nurse was putting the half ring together, it was noticed that the screw was broken and unable to tighten it onto the other half ring tightly.While tightening the blue holding base to the bed, the blue screw made a loud crack noise.It was unknown if the surgery completed successfully.There was no patient consequences are reported.This complaint involves (1) device.This report is for (1) synframe insulated table clamp.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFRAME INSULATED TABLE CLAMP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11073563
• Report Number: 8030965-2020-09962
• Device Sequence Number: 2602445
• Product Code: LXH
• UDI-Device Identifier: 10705034771120
• UDI-Public: (01)10705034771120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 387.346
• Device Catalogue Number: 387.346
• Device Lot Number: BAG0957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/25/2020
• Patient Sequence Number: 1