MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7207315

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

It was reported that, during a posterior cruciate ligament surgery, the "4.5 endoscopic cannulated drill bit" was dull and the surgeon could not use it.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7207315 sterile 4.5mm cannulated endoscopic drill bit used for treatment, was returned for evaluation.Provided states: ¿during a posterior cruciate ligament surgery, the "4.5 endoscopic cannulated drill bits" were dull and the surgeon could not use them¿.During apr 2019, smith and nephew made adjustments to the 7207315 4.5mm endoscopic cannulated drill bits grinding process that improved drilling performance when compared to older devices representative of the complaint units.During an engineering analysis, further evaluation of dimensional specifications was initiated for any improvement opportunities.Process improvements were incorporated for a tolerance inconsistency issue that affected sharpness of this product.Corrective action was initiated in (b)(6) 2019 to explore further drilling performance improvements.This lot was manufactured prior to the improvement.Rate of occurrence has declined since.Complaint history review indicated no similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation although occurrences drove an investigation resulting with the process improvement.Product met specifications upon release to distribution.Monitoring continues via rate of occurrences.

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10454447
• MDR Text Key: 204381143
• Report Number: 1219602-2020-01314
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010425409
• UDI-Public: 03596010425409
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: 7207315
• Device Catalogue Number: 7207315
• Device Lot Number: 2032597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1