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

Model Number	72201994
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder instability surgery, the anchor was found fractured and then removed with tweezers.The procedure was completed with a backup device and no delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3,h6: the reported 72201994 osteoraptor 2.9 w/ 1 ub cobraid blu , used in treatment, has been returned for evaluation.The information provided states: ¿during a shoulder instability surgery, the anchor was found fractured and then removed with tweezers¿.Visual assessment confirms complaint.Anchor was broken and remained attached to the suture.An exact root cause cannot be determined with confidence, however factors that could have contributed to the reported event include: excessive force.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.Further investigation is not warranted at this time.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10376687
• Report Number: 1219602-2020-01188
• Device Sequence Number: 3001696
• Product Code: MAI
• UDI-Device Identifier: 03596010615558
• UDI-Public: 03596010615558
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/29/2023
• Device Model Number: 72201994
• Device Catalogue Number: 72201994
• Device Lot Number: 50723923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR