MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9MM; BIT, SURGICAL

Model Number 72204044

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an arthroscopy surgery while drilling the femoral tunnel the trunav detached.The procedure was successfully completed without a significant delay using a back-up device.No 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

H10.H3, h6: one 72204044 retrograde drill used in treatment, was retuned for evaluation.Evaluation of the drill confirm the product was broken and returned in several pieces.There were scratches and dings in the distal area.The actuation wire was twisted and snapped.What remained attached of the actuation wire, did articulate.Symptoms were aligned with contact with other instruments or devices and torque was a factor.Reasons have been seen such as the estimated bone tunnel length was not correct or debris adequately cleared from the window to allow proper articulation of the blade.Per ifu: read these instructions completely prior to use.Warning: if resistance is felt when deploying the cutting blade, confirm that the black laser line on the drill head is visible out of the tunnel, guide wire is pulled back within the groove and no longer in the drill head window, and bone debris is cleared from drill head window.Take caution if bone debris removal is necessary to prevent any damage to the wire attached to the cutting blade.Note: to ensure that the cutting blade opens in the visual field, slowly rotate the retrograde drill until the ¿+¿ on the distal drill head or on the external orange cylinder is completely visible.Complaint history review indicated a similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to manufacturing was confirmed.Product met specifications upon release to distribution.There were no findings to suggest product did not pass requirements upon release for use.Occurrence rate of allegations are monitored via surveillance.No further investigation is warranted at this time.

Manufacturer Narrative

One 72204044 retrograde drill used in treatment, was retuned for evaluation.Compliant use according to ifu and product insert card are required.Evaluation of the drill confirm the product was broken and returned in several pieces.There were scratches and dings in the distal area.The actuation wire was twisted and snapped.What remained attached of the actuation wire, did articulate.Symptoms were aligned with contact with other instruments or devices and torque was a factor.Reasons have been seen such as the estimated bone tunnel length was not correct or debris adequately cleared from the window to allow proper articulation of the blade.Per ifu: read these instructions completely prior to use.Warning: if resistance is felt when deploying the cutting blade, confirm that the black laser line on the drill head is visible out of the tunnel, guide wire is pulled back within the groove and no longer in the drill head window, and bone debris is cleared from drill head window.Take caution if bone debris removal is necessary to prevent any damage to the wire attached to the cutting blade.Note: to ensure that the cutting blade opens in the visual field, slowly rotate the retrograde drill until the ¿+¿ on the distal drill head or on the external orange cylinder is completely visible.Complaint history review indicated a similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to manufacturing was confirmed.Product met specifications upon release to distribution.There were no findings to suggest product did not pass requirements upon release for use.Occurrence rate of allegations are monitored via surveillance.No further investigation is warranted at this time.

• Brand Name: RETROGRADE DRL 9MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10280238
• MDR Text Key: 199073161
• Report Number: 1219602-2020-01037
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037739
• UDI-Public: 00885554037739
• 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,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204044
• Device Catalogue Number: 72204044
• Device Lot Number: 4899147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention