MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; BONE STAPLE

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Irritation (1941); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Schipper, o; et al (2017) radiographic results of nitinol compression staples for hindfoot and midfoot arthrodeses.Foot & ankle international, 1-8.This report is for an unknown bme speedtitan staple.Part and lot numbers are unknown.The udi number is not available.(510k): unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.- (b)(4).

Event Description

This report is being filed after subsequent review of the following article: schipper, o; et al (2017) radiographic results of nitinol compression staples for hindfoot and midfoot arthrodeses.Foot & ankle international, 1-8.This a retrospective study from january 1, 2012, and december 31, 2016 to determine the radiographic union rate after midfoot and hindfoot arthrodeses using a new generation of nitinol staples, and to compare outcomes between a nitinol staple construct and a nitinol staple and partially threaded compression screw construct.A total of 96 patients and 149 joints met inclusion criteria.A single fellowship-trained foot and ankle surgeon performed all procedures.A new-generation bme elite staple was used for all cases, with or without a partially threaded screw.In cases where there was inadequate space for a bme elite staple, a thinner bridge bme speedtitan staple was used instead; biomedical enterprises elite, speedtitan; depuy synthes, leeds, united kingdom.In the nitinol staple group, (60/64) of patients had radiographic evidence of union.Of the 4 with nonunion, 2 were asymptomatic and did not request revision surgery and the other 2 patients, one of whom was a diabetic and underwent revision arthrodesis.(2/64) patients underwent removal of staples for hardware irritation.Of the 4 patients with nonunion, 3 had evidence of a broken staple and none required surgery for removal.In the staple and screw group (29/32) patients had radiographic evidence of union.Of the 3 patients with nonunion, 1 patient underwent revision arthrodesis and had evidence of a partial union of the talonavicular joint based on ct imaging, but had continued significant pain, requiring revision surgery.One nonunion had not yet undergone revision surgery, but she was symptomatic and in the process of being contacted for possible revision arthrodesis at the time of this study.The third nonunion patient was asymptomatic.Of these 3 patients, 2 had evidence of a broken staple and none required surgery for removal.This report is for an unknown bme speedtitan staple.This bme speedtitan report is for 6 unknown patients who experienced nonunion, 1 arthrodesis revision, 2 had hardware irritation with removal, 5 had broken staples.It was unknown which device was used.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Further it was clarified that 8 patients experienced bme implant breakage and not 5 as originally reported and total of 11 bme implants broke in these 8 patients.

Manufacturer Narrative

Investigation was performed based on x-rays provided.The complaint condition was visually confirmed and consistent with the reported condition.The x-rays show a total of 11 broken staples, specifically: three (3) speedtitan staples broken post operatively, two of which resulted in serious injuries and eight (8) speed staples broken post operatively, one (1) of which resulted in a serious injury.All serious injuries were due to non-unions and revision surgeries.A dhr review on these implants could not be performed since the lot numbers for the broken devices were not provided.Specific part numbers for the devices were not provided either, therefore, a drawing review cannot be performed.Devices were not returned to cq for device evaluation, therefore, material assessments or dimensional inspections could not be performed.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Further it was reported that it is unknown if the breaks are related to the speedtitan staple or the speed staple.

• Type of Device: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7069029
• MDR Text Key: 93281550
• Report Number: 2939274-2017-50066
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• 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