MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR 2.9 WITH 2 ULTRABRAID; SCREW, FIXATION, BONE

Model Number	72200775
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bancart and slap repairing, after drilling field with 2,7 mm drill device leaved from the grip.Patient bone was hard.Anchor was broken and all pieces were removed.Operation was completed with a titanium anchor by preparing new hole.
Additional Manufacturer Narrative
One 2.9 bioraptor ab assembly was returned for evaluation.Visual assessment of the device shows the nose cone and the sliding ring are free from the inserter handle.The nose cones retention tabs have been broken off.The anchor was not returned for evaluation.The suture was returned and shows no abnormalities.The condition of the device indicates it was subjected to excessive forces during use.

• Brand Name: BIORAPTOR 2.9 WITH 2 ULTRABRAID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7282934
• Report Number: 1219602-2018-00243
• Device Sequence Number: 13816869
• Product Code: HWC
• UDI-Device Identifier: 03596010585967
• UDI-Public: (01)03596010585967(17)180831(10)50563852
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K151105
• 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
• Report Date (Section B): 03/27/2018

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: 08/31/2018
• Device Model Number: 72200775
• Device Catalogue Number: 72200775
• Device Lot Number: 50563852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR