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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during bankart surgery, the suture cut into bone while tying and position of the suture anchor slightly moved out of the drill hole.The procedure was completed with the same device and with a significant delay.No patient injuries were reported.
Additional Manufacturer Narrative
The reported 2.9 osteoraptor anchor assembly for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided: the suture anchor slightly moved out of the drilled hole.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site with the correct drill.Pathological conditions in the bone that would prevent secure fixation of the device.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: 8884268
• Report Number: 1219602-2019-00952
• Device Sequence Number: 14135828
• 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: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 09/21/2023
• Device Catalogue Number: 72201994
• Device Lot Number: 50760626
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1