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

Catalog Number	72201881
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the anchor was broken when the anchor was inserted.It is unknown if a back up device was available or if a delay was caused by the device malfunction.No patient injuries were reported.
Additional Manufacturer Narrative
(b)(4).One dynomite 2.0mm peek anchor preassembled needles fixation device reported on for each of two complaints.The complaint stated: ¿the anchor was broken when the anchor was inserted.¿ this instrument is recommended for attachment of soft tissue to bone situations.The product has very specific prep instruction for use with only smith and nephew drill bits and guides.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.To prepare the insertion site, only use the smith and nephew drill guides and drill bits intended for use with the dynomite suture anchor or the implant may not be properly aligned.Inspect the drill bit for damage prior to use.Do not attempt to straighten or sharpen the drill bit.Sharpening will alter the implantation site and could affect anchor stability¿.Response to further questions were unsuccessful.No root cause associated with the manufacture of this device was determined.Request for further details was unsuccessful.It is unknown whether accompanying prep instrument and tools were smith and nephew products.No root cause associated with the manufacture of this device was confirmed.No further investigation warranted at this time.
Additional Manufacturer Narrative
One 72201881 dynomite 2.0mm peek anchor with needles fixation device used for treatment, was returned for evaluation.This instrument is recommended for attachment of soft tissue to bone situations.This device is not recommended for comminuted bone condition.Complaint search revealed one other complaint for the history of this production lot.The complaint stated: ¿the anchor broke when inserted.¿ the insertion device was returned.The handle and shaft are not damaged.The double needle and suture assembly was returned undamaged.They do not show evidence of use.The anchor was not returned and could therefore not be evaluated.Instruction for use stated that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.To prepare the insertion site, only use the smith and nephew drill guides and drill bits intended for use with the dynomite¿ suture anchor or the implant may not be properly aligned.Ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Establish and maintain axial alignment of the suture anchor to the drilled insertion site.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8565734
• Report Number: 1219602-2019-00484
• Device Sequence Number: 11225636
• Product Code: JDR
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 10/16/2022
• Device Catalogue Number: 72201881
• Device Lot Number: 50691041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/23/2019; 07/23/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/24/2019; 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1