MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE BIPASS SUTURE PUNCH; FORCEPS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).Device location unknown.

Event Description

During a rotator cuff repair, a piece of the suture passer jaw fractured and the piece could not be found.After a 30 minute delay, the procedure was completed without locating the fragment.One day post-operatively, a radiograph located the fragment in the patient and a procedure was performed to remove it.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Product was received and visually examined.The trapdoor on the top of the instrument has fractured off; therefore, the complaint is confirmed.The fractured piece was retrieved from the patient and was also sent along with the product.Review of device history records for this device identified no deviations or anomalies, and indicates the product was manufactured conforming to print specifications.This device is used for treatment.Investigation revealed that this device was manufactured in 2010, and that this issue has been addressed in previous corrective action in the form of a design change.The likely root cause is design related, with age/usage of the instrument also contributing.

Event Description

During a rotator cuff repair procedure, a piece of the trap door fractured and the piece could not be found.After a 30 minute delay, the procedure was completed without locating the fragment.One day post-operatively, a radiograph located the fragment in the patient and a procedure was performed to remove it.

• Brand Name: BIPASS SUTURE PUNCH
• Type of Device: FORCEPS
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5908833
• MDR Text Key: 53275555
• Report Number: 0001825034-2016-03363
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 902099
• Device Lot Number: 816490
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention