MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,CANNULA, ROTATABLE, S/V, 5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201693

Device Problem Scratched Material (3020)

Patient Problem Tissue Damage (2104)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an shoulder arthroscopy, the patient suffered cartilage damages in the humerus as a consequence of an existing gap between the 5.00 mm cannula tip-end (which has a sharp edge) and the arthroscope when connected.As this adverse consequence was noticed after the procedure, the surgery had been finished with the same device, in a timely manner.It is still unknown: (i) the outcome and evolution of the patient; and (ii) if there was any necessary revision surgical intervention to preclude any permanent damage to the cartilage.

Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, concise investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: MTO,CANNULA, ROTATABLE, S/V, 5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8201054
• MDR Text Key: 131581355
• Report Number: 1219602-2018-01819
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010605269
• UDI-Public: 03596010605269
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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 Catalogue Number: 72201693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other