MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR 2.9 WITH 1 ULTRABRAID; SCREW, FIXATION, BONE

Model Number	72200774
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was broken during insertion.All pieces of the screw were removed from the patient.A backup device was available to complete the procedure following a short delay.No patient impact was reported.
Additional Manufacturer Narrative
Device investigation narrative - one 2.9 bioraptor ab assembly was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The anchor has broken at the suture eyelet.The broken portion was not returned.The proximal end of the anchor remains attached to the inserter.The suture remains attached to the anchor and shows no abnormalities.The inserter shows no damage.Dimensional assessment of the anchor is prohibitive due to its condition.The condition of the anchor indicates excessive force was placed on the anchor during insertion likely causing the observed damage.Per the device ifu under precautions ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.Further investigation is not warranted at this time.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated c-(b)(4).

• Brand Name: BIORAPTOR 2.9 WITH 1 ULTRABRAID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6836626
• Report Number: 1219602-2017-01056
• Device Sequence Number: 18847131
• Product Code: HWC
• UDI-Device Identifier: 03596010585950
• UDI-Public: (01)03596010585950(17)181229(10)50579171
• Combination Product (Y/N): N
• PMA/510(K) Number: K031685
• 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
• Report Date (Section B): 09/21/2017

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: 12/29/2018
• Device Model Number: 72200774
• Device Catalogue Number: 72200774
• Device Lot Number: 50579171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR