MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPIC NEEDLE ST - BOX OF ONE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202825
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, when using the "arthroscopic needle st", the needle hit the bone and broke.All the pieces were successfully removed from the patient.The procedure was completed with a backup device and no delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72202825 used in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.If further information, becomes available, the complaint may be revisited.Per ifu 1061352: ¿the instruments are provided sterile for single use.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacture of the product was confirmed.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that, during surgery, when using the "arthroscopic needle st", the doctor spoke when hitting the product on the bone and the needle hit the bone and broke.All the pieces were successfully removed from the patient.The procedure was completed with a backup device and no delay or further complications were reported.

• Brand Name: ARTHROSCOPIC NEEDLE ST - BOX OF ONE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10495737
• Report Number: 1219602-2020-01358
• Device Sequence Number: 2720641
• Product Code: LXH
• UDI-Device Identifier: 00885554000443
• UDI-Public: 00885554000443
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202825
• Device Catalogue Number: 72202825
• Device Lot Number: 203908
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: Hospitalization; Required Intervention