MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHONDRAL PICK HANDLE ASSY; ARTHROSCOPE

Catalog Number	014800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the chondral pick broke when hit with a hammer, as indicated by technique.The tip was removed by the physician.The procedure was finished with a plaster instead to successfully complete the surgery.Neither surgical delay nor patient injuries have been indicated.
Additional Manufacturer Narrative
One 014800 chondral pick handle assembly was used for treatment but was not returned for evaluation.This is a nine year old reusable instrument component.The symptom is aligned with having blunt force applied but due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use (ifu) documentation confirms instructions, precautionary statements and recommendations for proper use of product.Instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.Per ifu: ¿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.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ product met specifications upon release to distribution.
Additional Manufacturer Narrative
One 014800 chrondral pick handle assembly used for treatment, was returned for evaluation.The complaint stated: ¿the chondral pick broke when hit with a hammer, as indicated by technique.¿ this was a nearly nine year old reusable pick.The incident is aligned with repeat instances of hammering.Tapping is recommended.The product has received high impact.Material has been crushed, dented and rolled from force.Inspection prior to each use is recommended.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.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ product met specifications upon release to distribution.No root cause related to the manufacturing of this product was confirmed.

• Brand Name: CHONDRAL PICK HANDLE ASSY
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8863976
• Report Number: 1219602-2019-00917
• Device Sequence Number: 2742579
• Product Code: HRX
• UDI-Device Identifier: 03596010026408
• UDI-Public: 03596010026408
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K940985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2020
• Device Catalogue Number: 014800
• Device Lot Number: 50367646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/27/2019; 10/30/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/28/2019; 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR