MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLT ASSY ANGLED DIRECTOR ACL; ACCESSORIES,ARTHROSCOPIC

Model Number 7205524

Device Problem Flaked (1246)

Patient Problem Injury (2348)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an acl reconstruction, metal sheddings were seen coming off in the joint.This was noticed in the femoral tunnel while the axcufex's 2.4 mm bullet guide was in contact with the passing pin.Most of the metal sheddings were removed from the knee joint with a mechanical shaver.The procedure was completed with the same bullet guide.There was no significant delay reported.The patient's outcome is as expected.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7205524 acl director angled bullet assembly used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.The allegation indicated shedding occurred when the bullet and guide wire made contact.If further information becomes available the complaint may be revisited.Instruction for use (ifu) documentation contains precautionary statements and recommendations for proper use of product.Per ifu: prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Insert the bullet into the bottom of the guide with the flat side of the bullet knob facing down.This allows ratchets to lock as the bullet slides into position.Complaint history review indicated similar allegations for the product family reported.Batch review was unattainable without a valid lot number reported.No indications suggest the product did not meet specifications upon release to distribution.No further investigation is warranted at this time.Without the requested clinical information, such as the relevant clinical information, radiographs, operative report, or the device the root cause of the reported material delamination cannot be determined.Per subsequent email, there was no information regarding the surgical technique, therefore, we cannot ruled out a procedural vs user error as a contributing factor.Additionally, it was not confirmed if all the metal shavings were completely removed.Since the metal shaving are not implantable, we cannot rule out the possibility of micro-motion or migration of the metal shavings.Per report, the procedure completed with the same device, with not significant delay and the impact to the patient was reported, ¿as expected¿.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint would be re-assessed.

• Brand Name: BLT ASSY ANGLED DIRECTOR ACL
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9901437
• MDR Text Key: 186150620
• Report Number: 1219602-2020-00570
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010373267
• UDI-Public: 03596010373267
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7205524
• Device Catalogue Number: 7205524
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other