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

Model Number	72201881
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor was broken, during a meniscus repair.No patient injuries were reported.
Additional Manufacturer Narrative
One (b)(4) dynomite 2.0mm peek anchor preassembled needles fixation device returned.The 2mm peek anchor was not returned.The suture and double needle suture assembly were not returned.The only item returned is the insertion handle with shaft.It does not display any damage.This product has very specific prep instruction to use only smith& nephew drill bits and guides.Fracture of this product anchor during procedure is typically from excess force during tapping the implant into location.To prepare the insertion site, only use the smith & nephew drill guides and drill bits intended for use with the dynomite suture anchor or the implant may not be properly aligned.The drill bit is to be inspected for damage prior to use.The drill bit is not to be straighten or sharpened.Sharpening will alter the implantation site and could affect anchor stability.Response to further questions communicated that a 1.6mm drill was used for a normal density bone.This size is aligned with recommendations.Subsequent question to verify that the drill bit was a smith & nephew instrument was unanswered.No root cause associated with the manufacture of this device was determined.
Additional Manufacturer Narrative
Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The 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: 7164265
• Report Number: 1219602-2018-00024
• Device Sequence Number: 1994201
• Product Code: JDR
• UDI-Device Identifier: 03596010619068
• UDI-Public: (01)03596010619068(17)201016(10)50570078
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2018

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: 10/16/2020
• Device Model Number: 72201881
• Device Catalogue Number: 72201881
• Device Lot Number: 50570078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 04/17/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/16/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR