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	12/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder superior labrum repair one suture was passed through the labrum and the other one was held and this suture was leaved from the anchor for an unknown reason.Anchor was not removed and an additional hole was made to complete the procedure, no significant delay or patient injury reported.
Additional Manufacturer Narrative
The complaint indicated that the procedure was ¿a shoulder superior labrum repairing¿.It says: ¿it was reported that during a shoulder superior labrum repair one suture was passed through the labrum and the other one was held and this suture was leaved from the anchor for an unknown reason.Operation was completed with knotless anchor.Anchor was not removed and an additional hole was made to complete the procedure¿.Per ifu, use of a 2.9mm drill guide obturator and bit are the recommended prep instruments.Surgical site preparation was listed as 2.9mm drill bit.Bone quality was indicated as normal.Drill size was appropriate.The ifu also details technique driven instructions and includes instructions specific to control of suture and tension.The 2.9mm pll anchor was not returned.The insertion device and suture was returned.The insertion device shows extensive damage.The damage represents excessive force or alternate manipulation of insertion shaft in attempts to reach desired surgical location.Per ifu precautions: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.Do not alter the implant or instrumentation, otherwise performance may be compromised.¿ no root cause related to the manufacturing of this device can be established.

• 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: 7186930
• Report Number: 1219602-2018-00068
• Device Sequence Number: 13699090
• Product Code: HWC
• UDI-Device Identifier: 03596010585950
• UDI-Public: (01)03596010585950(17)190122(10)50583950
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 01/22/2019
• Device Model Number: 72200774
• Device Catalogue Number: 72200774
• Device Lot Number: 50583950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1