MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207560
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the screw broke during insertion.A backup device was available to complete the procedure following a short delay of less than 30 minutes.No patient impact was reported.
Additional Manufacturer Narrative
Due to no product being returned the complaint could not be confirmed.Evaluation and investigation are not possible.No definitive conclusions can be made without pertinent manufacturing information or a device to evaluate.If relevant information becomes available to assist with traceability, the complaint will be revisited.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6836624
• Report Number: 1219602-2017-01055
• Device Sequence Number: 10779567
• Product Code: MAI
• UDI-Device Identifier: 03596010426222
• UDI-Public: (01)03596010426222(17)220111(10)50641106
• Combination Product (Y/N): N
• PMA/510(K) Number: K992936
• 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
• Report Date (Section B): 11/02/2017

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: 01/11/2022
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50641106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1