MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 8MM X 20MM STRL; SCREW, FIXATION, BONE

Model Number	7207918
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the doctor used the guides and drill bits, which are needed to place the 8x20 screw, but at the moment of placing it, it was loose and the graft was loosed too, for this reason, they decided to remove it in order to put it back again, but the noticed that the tip was missing a piece.Then, they proceeded to remove what was left of the screw inside the patient and place a 9x30 screw, which worked properly.No patient injury was reported.
Additional Manufacturer Narrative
Visual assessment of the screw confirmed the reported breakage.The distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter was found to meet print specification.Clinical details were provided confirming the surgeon used a notched dilator to prepare the insertion site.Per the device ifu under warning: the starter must be utilized with the biorci screws to minimize screw breakage during insertion.If hard bone is encountered as in this case, the biorci tap should be used.
Additional Manufacturer Narrative
Device has not been returned for evaluation.Clinical details were provided confirming the surgeon used a notched dilator to prepare the insertion site.Per the device ifu 1061039 under warning: the starter must be utilized with the biorci screws to minimize screw breakage during insertion.If hard bone is encountered as in this case, the biorci tap should be used.

• Brand Name: BIORCI SCRW 8MM X 20MM STRL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7163491
• Report Number: 1219602-2018-00016
• Device Sequence Number: 1407824
• Product Code: HWC
• UDI-Device Identifier: 03596010485540
• UDI-Public: (01)03596010485540(17)220628(10)50671991
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2018

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 Expiration Date: 06/28/2022
• Device Model Number: 7207918
• Device Catalogue Number: 7207918
• Device Lot Number: 50671991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/23/2018; 03/14/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/29/2018; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 55