MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72201881
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the anchor broke.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
Only the inserter from the reported dynomite 2.0 pk w/needles was returned for evaluation.Visual assessment of the inserter showed no abnormalities.Without the return of the anchor 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: off axis insertion.Not preparing the insertion site with the correct instrumentation.The instruction for use were reviewed and were 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 lot did not meet product specifications upon release into distribution.

• Brand Name: DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8789601
• Report Number: 1219602-2019-00813
• Device Sequence Number: 19499800
• Product Code: MBI
• UDI-Device Identifier: 03596010619068
• UDI-Public: 03596010619068
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081511
• 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): 08/16/2019

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: 12/28/2023
• Device Catalogue Number: 72201881
• Device Lot Number: 50778289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1