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	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw broke while tightening.No patient injury was reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.
Additional Manufacturer Narrative
One 7207564 sterile 9x30mm biorci screw reported on.The screw, ifu, chartstik labels, foil inner pouch and the outer product carton were returned.Dimensional inspection verifies that this was a 9x30mm product.Threads have been chewed up at the distal tip.This has been known to occur from entanglement with the guide wire.The head has indication of stripping from excess torque.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.If hard bone is encountered, the biorci tap should be used.Attempts for further prep information were not successful.No root cause related to the manufacturing of this device was confirmed.

• 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: 7632803
• Report Number: 1219602-2018-00809
• Device Sequence Number: 16573868
• Product Code: HWC
• UDI-Device Identifier: 03596010426260
• UDI-Public: (01)03596010426260(17)221106(10)50695211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

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: 06/11/2022
• Device Model Number: 7207564
• Device Catalogue Number: 7207564
• Device Lot Number: 50695211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 09/11/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 07/26/2018; 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1