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	06/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, the anchor broken when it was inserted.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, has not been returned for evaluation.Without the reported product and pertinent clinical details a thorough evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: misalignment with the drilled hole.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 2.9 osteoraptor assembly was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The distal end of the anchor has broken at the suture eyelet; the broken portion was not returned for examination.Dimensional assessment of the anchors major diameter confirmed it met print specification.The inserter and suture show no abnormalities.From the information provided, the anchor broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith + nephew drill prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8626453
• Report Number: 1219602-2019-00574
• Device Sequence Number: 2169054
• Product Code: MAI
• UDI-Device Identifier: 03596010615558
• UDI-Public: 03596010615558
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 07/09/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 06/17/2019; 07/08/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/18/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 68