MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72201806
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the anchor hole was blocked.The device broke into the patient and the pieces were removed.The procedure was successfully completed without considerable delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 3.0 raptormite pk w/needles intended for use in treatment, was not 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 anchor broke during insertion, causing the anchor to break into pieces.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.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 3.0 pk raptormite w/needles was returned for evaluation.Visual assessment of the device shows the anchor has broken where the insertion device distal tip interfaces.The broken portion of the anchor was not returned for examination.Dimensional assessment of the remaining portion of the anchor was found to meet print specifications.The condition of the device is consistent with off axis insertion and the application of excessive force during insertion.No root cause related to the manufacturing process can be established.

• Brand Name: RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8487741
• Report Number: 1219602-2019-00393
• Device Sequence Number: 19200290
• Product Code: MBI
• UDI-Device Identifier: 03596010619082
• UDI-Public: 03596010619082
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K071586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2019

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: 10/01/2023
• Device Catalogue Number: 72201806
• Device Lot Number: 50765031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 08/13/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/26/2019; 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1