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

Model Number	72201811
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the dynomite 2.0 pk was opened as requested by surgeon.Appropriate 1.6 drill used.Surgeon opted not to tap, advanced screw by hand.Twisted gray bit of handle counterclockwise 90 degrees to release anchor.Reported that as surgeon withdrew the orange handle, the suture threads attached to the anchor just freely detached and separated together with the needles.Anchor was still in bone.Surgeon asked to open another dynomite anchor.Same drill used.Same technique used.Dynomite anchor was implanted successfully.No other incident encountered.Slight delay to surgery.No patient injury was reported.
Additional Manufacturer Narrative
Peek anchor device with needles fixation was returned.The reported procedure was a wrist arthrodesis.This device is not recommended for comminuted bone condition.This instrument is recommended for attachment of soft tissue to bone situations.The device shaft and handle was not damaged.The 2mm anchor and attached suture double needle assembly were not returned.The prep drill size was reported to be the recommended size.It was not confirmed whether the drill was the dynomite required drill specified for this product¿s use.The complaint also stated that the surgeon chose to deviate from the instructions for use recommendations for insertion of the anchor by screwing vs tapping or pushing the anchor into location.No root cause associated with the manufacture of this device was established.

• 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: 7396114
• Report Number: 1219602-2018-00387
• Device Sequence Number: 11197762
• Product Code: MBI
• UDI-Device Identifier: 03596010609793
• UDI-Public: (01)03596010609793(10)50598646
• Combination Product (Y/N): N
• 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): 05/17/2018

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: 05/24/2021
• Device Model Number: 72201811
• Device Catalogue Number: 72201881
• Device Lot Number: 50598646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR