MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 5MM OFFSET (RED); ACCESSORIES,ARTHROSCOPIC

Model Number	72201715
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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 offset 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 offset 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.
Additional Manufacturer Narrative
H2, h6.72201715 5mm offset endofemoral aimer instrument used for treatment, was not returned for evaluation.The product is reusable instrument used as part of a multi component set-up.The allegation indicated shedding occurred when the bullet and guide wire made contact.Evaluation was limited.Instructions for use contains precautionary statements and recommendations for proper use of product.Per instructions for use: these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.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.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 has not been 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.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) per report, during an acl reconstruction, metal shedding¿s were seen coming off in the joint.This was in the femoral tunnel while the offset guide was in contact with the passing pin captured under (master(b)(4) previously closed).According to the sales rep., this was noticed during femoral tunnel drilling it was in contact with the universal handle 72201732 captured under complaint((b)(4)), the offset guide 72201715 captured under this complaint ((b)(4)), both were reported as brand new.Additionally, during tibial tunnel drilling it was in contact with the 2.4mm bullet guide 7205524 ((b)(4)) from the acufex director tibial aiming system.Most of the metal shedding was removed from the knee joint with a mechanical shaver.The procedure was completed with the same offset guide.There was no significant delay reported.The patient's outcome is as expected.Conclusion: 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 has not been 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.Approved by (b)(6) md on (b)(6) 2020.

• Brand Name: AIMER ENDOFEMORAL 5MM OFFSET (RED)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9901389
• Report Number: 1219602-2020-00569
• Device Sequence Number: 11319049
• Product Code: NBH
• UDI-Device Identifier: 03596010608208
• UDI-Public: 03596010608208
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 72201715
• Device Catalogue Number: 72201715
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other