MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKLING UPBTR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	012045
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscal resection the bottom jaw broke.All pieces were removed successfully.It is unknown if a backup was available and how the issue was resolved.There was no significant delay and no patient injury or other complications reported.
Additional Manufacturer Narrative
Additional information one duckling upbiter was returned for evaluation.The device is over fifteen years old and is worn.Visual assessment of the device confirmed the reported complaint of breakage.The distal tip of the shaft has broken off.The tips cutting edge is uneven.Dimensional assessment of the broken tip found it under print specification.The devices condition indicates it was repaired by an unauthorized third party leading to the breakage.We recommend that all re-usable instruments be routinely inspected for wear/damage and be repaired or replaced as necessary.

• Brand Name: PCH BSKT DCKLING UPBTR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8194068
• Report Number: 1219602-2018-01777
• Device Sequence Number: 1770798
• Product Code: NBH
• UDI-Device Identifier: 03596010023995
• UDI-Public: 03596010023995
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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 Catalogue Number: 012045
• Device Lot Number: L504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1