MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MEMOFIX STAPLE 10MM X 10MM X 10MM; MEMOFIX STAPLE SYSTEM

Catalog Number MS101010

Device Problems Break (1069); Failure to Fire (2610)

Patient Problems Failure of Implant (1924); Injury (2348); Arthralgia (2355); No Code Available (3191)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the patient presented to surgeons office with complaint of wrist pain at the beginning of (b)(6) 2017.X-rays revealed broken staple.Pt scheduled for surgical removal on (b)(6) 2017.Staple was removed without incident on (b)(6) 2017.Stt joint was well fused.No further surgical intervention was required.Staple placed intraoperatively for stt fusion of wrist on (b)(6) 2017.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.As the lot number was not reported and the part not returned, a review of the lot record could not be conclusive.A review of the complaint records for the same product for the alleged hazardous situation/failure mode (insert inserter breaking) showed nine complaints for this instrument having been received during the lifetime of the product.As the staple was not returned, a likely root cause could not be determined.If the part is returned at a later date, this complaint will be reopened and updated.

• Brand Name: MEMOFIX STAPLE 10MM X 10MM X 10MM
• Type of Device: MEMOFIX STAPLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6861476
• MDR Text Key: 85942297
• Report Number: 1651501-2017-00037
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K123926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS101010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention