MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MEMOFIX STAPLE 12MM X 10MM X 10MM; MEMOFIX STAPLE SYSTEM

Catalog Number MS121010

Device Problems Break (1069); Fracture (1260)

Patient Problems Therapeutic Response, Decreased (2271); No Information (3190)

Event Date 04/30/2015

Event Type  Injury  

Event Description

Surgeon performed an interphalangeal joint (ipj) fusion with 1 memofix staple 12mm x10mm x10mm staple (b)(6) 2015.Staple was placed in a dorsal medial fashion.Patient was put in a post-op surgical shoe.Patient fractured staple within 7-10 days after surgery.Patient was brought back to surgery to remove broken staple and put in a 3.0mm x 40mm titanium cannulated screw (b)(6) 2015.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Office staff person reported via phone july 23, 2015.The patient is doing well now.Integra has completed their internal investigation on june 30, 2015.The additional investigation activities included.Methods: evaluation of actual device, review of device history records, review of complaint history.Results: the device lot number was not provided, and the returned part is not marked with the lot number, therefore, a review of the manufacturing records of the ms121010 lots received since product inception in 2013 was performed five manufacturing lots were received during this time period.The review found one lot (10104-05, rev 7) where 7 of the (b)(4) pieces were rejected and returned to the supplier one staple was found with a gouge at the end of a leg and 6 more had the barbs rounded off and the leg lengths under the lower limit.The nonconforming units were returned to the supplier and not distributed.Based on this review, no product/manufacturing problems were identified that would have likely caused or contributed to the event.A review of the metasurg complaint files since 2013 showed three additional complaints for fractured staples.There have been (b)(4) ms121010 staples received.The complaint rate for fractured staples is (b)(4).Conclusion: no definite root cause could be concluded from the information provided.Previous investigations have determined staple fracture after surgery could be attributed to the surgical technique, including failure to use additional staples needed to stabilize the bone or to prevent excessive functional stress.Patient failure to follow post-operative recommendations is also a potential root cause.

• Brand Name: MEMOFIX STAPLE 12MM X 10MM X 10MM
• Type of Device: MEMOFIX STAPLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4804286
• MDR Text Key: 5925677
• Report Number: 1651501-2015-00013
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS121010
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 41 YR