MAUDE Adverse Event Report: OSTEOMED INSTAFIX; INSTAFIX STAPLE IMPLANT KIT, 10 X 10 MM

Catalog Number	400-3703-SP
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instafix staple implant kit, 10x10mm, p/n 400-3703-sp, contains a delivery device that is loaded with the 10x10mm staple.In this complaint, the surgeon had difficulty releasing the staple from the delivery device.While attempting to release the staple, the bone fractured.The root cause for the difficulty releasing the staple could not be determined.The two 10 x 10mm staples were implanted into the patient.Evaluation of the returned pair of delivery devices did not reveal anything that could be determined to have hindered the delivery of either staple.As for the bone fracture, the complainant stated that the patient had "very soft bone".This condition is contraindicated for this system.The review of the dhr did not identify any non-conformances associated with product release.A two-year review found no related capas or ncrs associated with 400-3703-sp kits.A two-year review of complaints identified one (1) similar complaint associated with fracture incident, and this is the first complaint associated with difficulty to deploy.The instafix 10x10mm staple kit is a part of the instafix shape memory fixation system.The instafix risk document includes an assessment of risk of a fractured bone.The severity rating is a 3.Per the risk management procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).Depending on the possible cause, the predicted risk level is either a "medium" or a "high".The risk of the staple not being able to release from the inserter body is not covered in the current revision of the fmea.A change notice has been initiated to add this risk to the fmea.The instafix instructions for use (ifu) outlines the steps for staple delivery; load staple legs into drilled holes, slide window (lid) proximally on the delivery device, pivot forward to disconnect the implant, and then tap the staple into position.A patient with insufficient quantity or quality of bone is listed as a contraindication for this system.This issue will be monitored through routine trending.
Event or Problem Description
On 06/20/2019 osteomed was notified of an adverse event related to the instafix staple implant kit, 10 x 10 mm.Per our representative, the physician opened joint and rongeured off distal and proximal portion of joint and stabilized with k-wire.When putting in the k-wire, part of the bone fractured off.He then drilled and placed an 8x8 instafix staple.He decided to place a 10x10 staple.He drill and began to place the staple.He struggled to remove 10x10 staple from inserter, during this time patient's bone fractured.He considered removing the staple and decided against it.He then added a 2nd 10x10 staple, although he struggled to get the staple off the inserter again, he was able to do it without further injury.He left all 3 staples intact and felt that he had reasonable compression.

• Brand Name: INSTAFIX
• Common Device Name: INSTAFIX STAPLE IMPLANT KIT, 10 X 10 MM
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8776407
• Report Number: 2027754-2019-00011
• Device Sequence Number: 1889739
• Product Code: JDR
• UDI-Device Identifier: 00842528104187
• UDI-Public: 00842528104187
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 400-3703-SP
• Device Lot Number: 20620211903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR