MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207561
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken at the surgery.No patient injury was reported.
Additional Manufacturer Narrative
One 8x30mm biorci ha screw was returned for evaluation.Visual assessment of the device confirmed the reported breakage.Approximately 1.5mm of the screws distal threads have broken off and were not returned.Dimensional assessment of the screws major diameter and wall thickness were found to meet print specification.This investigation could not identify any evidence of product contribution to the reported complaint.With the limited clinical details provided a root cause cannot be determined.

• Brand Name: SCR BIORCI 8X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7935325
• Report Number: 1219602-2018-01378
• Device Sequence Number: 931008
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: (01)03596010426239(17)221106(10)50695207
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 7207561
• Device Catalogue Number: 7207561
• Device Lot Number: 50695207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1