MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE INSTRUMENT, CURVED LEFT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201186

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that the top jaw of the arthro pierce curved left broke off and was retained in the patient.Two pieces broke off of the instrument.One piece was removed, but the other piece is retained in the patient.Patient will be re-x-rayed in 4 weeks and may have removal surgery.The procedure was delayed by about 15 minutes.Another suture passer ((b)(6)) was used to complete the case.It is reported that the patient is currently recovering well.

Manufacturer Narrative

Device investigation narrative - one arthropierce curved left was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The distal tip of the shaft has been broken off.The tip and movable jaw were not returned for examination.The break area is played and shows signs of plastic deformation.Dimensional and material specifications were inspected and found to meet print specification.This condition is consistent with excessive forces being applied during use.Per the devices ifu under precautions ¿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¿.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.(b)(4).

• Brand Name: ARTHROPIERCE INSTRUMENT, CURVED LEFT
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5823149
• MDR Text Key: 50474730
• Report Number: 1219602-2016-00438
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 72201186
• Device Lot Number: 50452753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• 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
• Patient Outcome(s): Required Intervention