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

Catalog Number 012045

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2018

Event Type  malfunction  

Event 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.

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
• 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: 8194068
• MDR Text Key: 131375255
• Report Number: 1219602-2018-01777
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023995
• UDI-Public: 03596010023995
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 12/24/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/29/2019
• 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: Reuse
• Patient Sequence Number: 1