MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN EASY CLIP STAPLE IMPLANT; STAPLE, FIXATION, BONE

Catalog Number UNK_SEL

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

Patient Problems Arthritis (1723); Loss of Range of Motion (2032)

Event Date 10/01/2013

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged postoperative stiffness could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of literature published by the ¿department of orthopaedic surgery, az sint-jan, brugge, belgium and department of orthopaedic surgery, university hospital brussels, belgium.¿the title of this report is ¿addition-subtraction osteotomy without ligamentoplasty for symptomatic trapezial dysplasia with metacarpal instability¿, published on october 01, 2013, which is associated with the stryker ¿easyclip staple implant¿.This report includes analysis of the clinical data that was collected on 8 patients and the cases in this study ranged from 2008 and 2011.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 1 patient experienced postoperative stiffness.The report also states, ¿only one patient hesitated, due to an increased postoperative stiffness which might be partially caused by progression of osteoarthritis.This had a repercussion on daily activities, although she experienced a decrease of pain after the operation".

Manufacturer Narrative

Correction: h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.Link to the published article: https://pubmed.Ncbi.Nlm.Nih.Gov/33454155/.

Event Description

The manufacturer became aware of literature published by the ¿department of orthopaedic surgery, az sint-jan, brugge, belgium and department of orthopaedic surgery, university hospital brussels, belgium.¿the title of this report is ¿addition-subtraction osteotomy without ligamentoplasty for symptomatic trapezial dysplasia with metacarpal instability¿, published on october 01, 2013, which is associated with the stryker ¿easyclip staple implant¿.This report includes analysis of the clinical data that was collected on 8 patients and the cases in this study ranged from 2008 and 2011.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 1 patient experienced postoperative stiffness.The report also states, ¿only one patient hesitated, due to an increased postoperative stiffness which might be partially caused by progression of osteoarthritis.This had a repercussion on daily activities, although she experienced a decrease of pain after the operation ¿.

• Brand Name: UNKNOWN EASY CLIP STAPLE IMPLANT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14190189
• MDR Text Key: 289949623
• Report Number: 0008031020-2022-00193
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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): Other