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

Catalog Number	72201994
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a shoulder surgery, the ultrabraid suture broke while it was pulling after inserting into glenoid.A backup device was available to complete the procedure with no significant delay and no patient injuries.Additional bone hole was drilled.
Additional Manufacturer Narrative
One 2.9mm osteoraptor device used for treatment, was not returned for evaluation.Due to product unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.Influences that could compromise product performance or integrity include: 1.Use of other than recommended prep instrument size or types.2.Getting entangled up with other instruments or devices.3.Stripping or over-torque.4.Damaged prep instruments.5.Unexpected bone density/condition.Per instructions for use: ¿do not use sharp instruments to manage or control the suture.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith and nephew drill prior to implantation¿.Note: when using osteoraptor 2.3 mm suture anchors, use a smith and nephew 2.3 mm in-line drill guide, 2.3 mm obturator, and a drill bit specific to the suture anchors to prepare the insertion site (each sold separately).Product met specifications upon release to distribution.Complaint history review found no other report for this lot.

• 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: 8666205
• Report Number: 1219602-2019-00652
• Device Sequence Number: 16721533
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 05/30/2023
• Device Catalogue Number: 72201994
• Device Lot Number: 2016154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1