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

Model Number	705464
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.Device disposition is unknown.
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
D9 / h3 corrected to indicate device was returned, h6 results and h6 conclusion codes updated.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.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 the 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: ANGLED FARABEUF CLAMP FOR 3.5MM SCREWS PRO
• Common Device Name: CLAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12150154
• Report Number: 0008031020-2021-00300
• Device Sequence Number: 3713650
• Product Code: HXD
• UDI-Device Identifier: 07613327131901
• UDI-Public: 07613327131901
• 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
• Report Date (Section B): 11/08/2021

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: 705464
• Device Catalogue Number: 705464
• Device Lot Number: 04855V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown