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

Catalog Number	72201994
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a surgery when the physician tried to do the knots, the suture broke and was not able to tie it down the labrum.He asked to waive this implant and new implant was opened.A 2.9 drill sleeve was used to prepare the insertion site.The anchor was left inside as it was deep into the bone there was not delay on the case and patient injury was not reported.
Additional Manufacturer Narrative
The reported 2.9 osteoraptor, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the suture broke during use, causing the anchor to be rendered surgically ineffective and left within the patients bone.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of a sharp instrument to manage or control the suture.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.Since no patient injuries were reported and a back-up device was used no further medical assessment is warranted.

• 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: 8198380
• Report Number: 1219602-2018-01803
• Device Sequence Number: 19380693
• Product Code: MAI
• UDI-Device Identifier: 03596010615558
• UDI-Public: 03596010615558
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2019

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: 02/16/2023
• Device Catalogue Number: 72201994
• Device Lot Number: 50715153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 02/15/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/31/2019; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1