MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207564
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was broken during placing.The procedure was completed without any further problems and there was no patient injuries reported.
Additional Manufacturer Narrative
Examination is not possible, as the device has not been returned.The clinical details provided were reviewed and no mention of a starter was mentioned.In addition it was reported that an 8mm tunnel was utilized with this screw (9mm).Per the device warning: the starter must be utilized with the biorci screws to minimize screw breakage during insertion.The ifu also instruct the end user to "choose an appropriate size biorci screw", in this instance would have been an 8mm screw which was ultimately used to complete the procedure.
Additional Manufacturer Narrative
One 9x30mm biorci screw was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.Approximately 2mm of the distal threads have broken off and were not returned for evaluation.Dimensional assessment of the screws major diameters and was thickness was performed and found within print specifications.The clinical details provided were reviewed and no mention of a starter was mentioned.In addition it was reported that an 8mm tunnel was utilized with this screw (9mm).

• Brand Name: SCR BIORCI 9X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7752304
• Report Number: 1219602-2018-00996
• Device Sequence Number: 13937811
• Product Code: HWC
• UDI-Device Identifier: 03596010426260
• UDI-Public: (01)03596010426260(17)230302(10)50718165
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2018

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 Model Number: 7207564
• Device Catalogue Number: 7207564
• Device Lot Number: 50718165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 10/09/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/30/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR