MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 7209497

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/18/2018

Event Type  malfunction  

Event Description

The tip of the arthropierce broke off inside the joint while trying to pass suture during an arthroscopic labral repair.There was about an hour delay.No patient injury reported.

Manufacturer Narrative

One arthropierce 45 degree curved right was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The distal tip of the shaft has broken off.The tip and movable jaw were not returned for examination.The break area is splayed and shows signs of plastic deformation.The condition of the device indicates it was subjected to excessive force during use.No root cause related to the manufacturing process can be established.

• Brand Name: ARTHROPIERCE 45 DEG RIGHT
• 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
• MDR Report Key: 7535469
• MDR Text Key: 108996193
• Report Number: 1219602-2018-00636
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474520
• UDI-Public: (01)03596010474520(10)50568021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209497
• Device Catalogue Number: 7209497
• Device Lot Number: 50568021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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
• Patient Age: 39 YR