MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72201994
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon anchoring the anchor onto the bone, the surgeon tried to give a light tug on the suture that comes together with anchor to ensure the anchor did anchor well onto the bone.However while surgeon did this, the sutures gotten dislodged from the anchor.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Examination is not possible, as the device was not returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Event or Problem Description
It was reported that upon anchoring the anchor onto the bone, the surgeon tried to give a light tug on the suture that comes together with anchor to ensure the anchor did anchor well onto the bone.However while surgeon did this, the sutures gotten dislodged from the anchor.The anchor was left secured inside the patient.A backup device was used and a new hole was made to complete the surgery.No significant delay or patient injury reported.

• Brand Name: OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7509696
• Report Number: 1219602-2018-00578
• Device Sequence Number: 2527614
• Product Code: MAI
• UDI-Device Identifier: 03596010615558
• UDI-Public: (01)03596010615558(17)220124(10)50643607
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 01/24/2022
• Device Model Number: 72201994
• Device Catalogue Number: 72201994
• Device Lot Number: 50643607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/13/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1