MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DILATOR,9-10MM, BIOSURE SYNC; ACCESSORIES,ARTHROSCOPIC

Model Number	72202757F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal tab on top of the punch broke off.The pieces were removed from the patient.No injury was reported.
Additional Manufacturer Narrative
One 72202756 biosure 9-10mm dilator returned.This is a ten year old reusable instrument.The complaint stated: "it was reported that the metal tab on top of the punch broke off.The pieces were removed from the patient.No injury was reported." the dilator impactor foot is absent.There is a portion of dilator shaft has been broken at the proximal end of the handle.This piece was not returned.The delrin handle has been quite gouged and scratched from repeated uses.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Further investigation is not warranted at this time.The delrin shows material etching.The condition consistent with use of incompatible cleansing agents.Low sudsing neutral 6.0-8.0 ph, enzymatic detergents are recommended".The deterioration occurs with incompatible cleaning agents.The etching contributes to material degradation and potential loss of integrity of the handle.No root cause related to the manufacturing process was established.

• Brand Name: DILATOR,9-10MM, BIOSURE SYNC
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7787823
• Report Number: 1219602-2018-01076
• Device Sequence Number: 1350878
• Product Code: NBH
• UDI-Device Identifier: 00885556573358
• UDI-Public: (01)00885556573358(10)50346252
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72202757F
• Device Catalogue Number: 72202757
• Device Lot Number: 50346252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1