MAUDE Adverse Event Report: STRYKER GMBH FARABEUF CLAMP FOR 3.5MM SCREWS PRO

Model Number	705463
Medical Device Problem Codes	Positioning Failure (1158); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "the physician was attempting to reduce the pelvic wing to the sacrum using the farabeuf clamp.The clamp continually slipped and wouldn¿t lock properly.The physician used both the angled and the straight farabeuf clamp during the surgery but both of them kept coming undone.These clamps are supposed to stay locked once they are positioned." additional information: procedure was completed using synthes clamps.
Event or Problem Description
As reported: "the physician was attempting to reduce the pelvic wing to the sacrum using the farabeuf clamp.The clamp continually slipped and wouldn¿t lock properly.The physician used both the angled and the straight farabeuf clamp during the surgery but both of them kept coming undone.These clamps are supposed to stay locked once they are positioned." additional information: procedure was completed using synthes clamps.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Correction: please refer to d9/h3 & h6 method code, results and conclusion codes -product returned for investigation.The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection has shown that the device is in a used condition, the ratchet mechanism has slight wear marks and there are different discolorations from often reprocessing visible.The device was attached to an bone model by using the compression mode.The complained slipping and not locking cannot be reproduced, the ratchet mechanism does lock and stay in position as required when the clamp is compressed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was most likely caused by unintentionally using the clamp in distraction instead of compression mode.In this relation following statement from the operative technique can be pointed out: "[both farabeufs feature a ratchet mechanism that enables compression or distraction settings.Flip the bar labeled ¿c¿ to put clamp in compression mode, or reverse it to display ¿d¿ for distraction mode.]" [original statement] if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the physician was attempting to reduce the pelvic wing to the sacrum using the farabeuf clamp.The clamp continually slipped and wouldn¿t lock properly.The physician used both the angled and the straight farabeuf clamp during the surgery but both of them kept coming undone.These clamps are supposed to stay locked once they are positioned." additional information: procedure was completed using synthes clamps.

• Brand Name: FARABEUF CLAMP FOR 3.5MM SCREWS PRO
• Common Device Name: CLAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12150373
• Report Number: 0008031020-2021-00301
• Device Sequence Number: 3713651
• Product Code: HXD
• UDI-Device Identifier: 07613327131918
• UDI-Public: 07613327131918
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 705463
• Device Catalogue Number: 705463
• Device Lot Number: L14662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 10/13/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 09/02/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1