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	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the screw broke when entering the tunnel.A backup device was used to complete the surgery.There was a surgical delay greater than 30 minutes.
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.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
Corrected.

• 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: 7870606
• Report Number: 1219602-2018-01243
• Device Sequence Number: 2488975
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: (01)03596010426239(17)221128(10)50699549
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,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: 11/28/2022
• Device Model Number: 7207561
• Device Catalogue Number: 7207561
• Device Lot Number: 50699549
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 10/22/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1