MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ST STAPLE 10MM 90 DG SINGLE; STAPLE,FIXATION,BONE

Catalog Number WGSPV0931

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.When the investigation is complete, it will be provided on a supplemental report.

Event Description

It was reported that the patient was running up stairs and tripped and caught toe on the stairs.Some time later the patient fell down stairs.The patient underwent a revision surgery due to a painful 1st mtp joint.(also noted: bony injury to lateral aspect 1st metatarsal head with dorsal fragment.Procedure performed: removal of metalwork, cheilectomy, debridement of joint and release of joint.X-ray and ct scan indicated there might be a partial collapse of the lateral aspect of the 1st metatarsal head.Finding during procedure: ¿the joint is very still.Release of the joint and identification of the distal screw and the staple in the proximal phalanx and both are removed.Step by step release of the joint.On the lateral side, there is a bit of stiffness and prominent bone as we knew from the x-ray and that is resected.Plantarly the sesamoids are released and the range of movement gradually improves step by step.Now also removal of the proximal screw.Overall, there is no sign of avn or a collapse of the lateral aspect of the 1st metatarsal head.In order to increase the range of movement, bone is removed from the dorsal aspect of the proximal phalanx and a bit from the metatarsal head.6 weeks after the revision the patient presented with stiffness in big toe joint but forced dorsiflextion does not trigger more pain.Griding test does not reproduce any pain and no crunching sensation.

Manufacturer Narrative

The reported event (pain) could be confirmed, since review of medical records confirm the device was removed due to pain the patient was experiencing.The patient had a history of procedures performed at the implant site and surrounding anatomy.There was also a patient fall noted prior to the patient's first revision surgery of the screws and staples.It was noted that the patient's postoperative healing process after implant was unremarkable until the impact trauma.Medical affairs was also consulted on the details of this case.According to their review, "the documentation of the surgeons and the involved medical health care personnel is pretty comprehensive, but i did not reveal anything which could help identify a specific cause for the failure." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient was running up stairs and tripped and caught toe on the stairs.Some time later the patient fell down stairs.The patient underwent a revision surgery due to a painful 1st mtp joint.(also noted: bony injury to lateral aspect 1st metatarsal head with dorsal fragment.Procedure performed: removal of metalwork, cheilectomy, debridement of joint and release of joint.X-ray and ct scan indicated there might be a partial collapse of the lateral aspect of the 1st metatarsal head.Finding during procedure: ¿the joint is very still.Release of the joint and identification of the distal screw and the staple in the proximal phalanx and both are removed.Step by step release of the joint.On the lateral side, there is a bit of stiffness and prominent bone as we knew from the x-ray and that is resected.Plantarly the sesamoids are released and the range of movement gradually improves step by step.Now also removal of the proximal screw.Overall, there is no sign of avn or a collapse of the lateral aspect of the 1st metatarsal head.In order to increase the range of movement, bone is removed from the dorsal aspect of the proximal phalanx and a bit from the metatarsal head.6 weeks after the revision the patient presented with stiffness in big toe joint but forced dorsiflextion does not trigger more pain.Griding test does not reproduce any pain and no crunching sensation.

• Brand Name: ST STAPLE 10MM 90 DG SINGLE
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18318723
• MDR Text Key: 330385089
• Report Number: 3010667733-2023-00766
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: WGSPV0931
• Device Lot Number: 161468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention