MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN EASYCLIP STAPLE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf from university of kentucky, usa.The title of this report is ¿a retrospective data collection of hand and foot bone fragments osteotomy fixation and joint arthrodesis with the easyclip staples¿ which is associated with the stryker ¿easyclip¿ system.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 2 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses deep infection treated with irrigation, debridement and antibiotics.The report states: ¿one subject, with a past medical history of obesity and previous tobacco use, was treated with joint arthrodesis as part of a surgery a non-union of a previous scaphoid fracture that was sustained during a motor vehicle accident.Healing went well with clinical and radiographical consolidation 318 days postoperatively.This subject developed a deep infection noted 497 days after the initial surgery.One irrigation and debridement procedure was performed 557 days after initial surgery.The hardware was retained, and antibiotics were given for three months.The subject recovered well and was noted to be consolidated and resolved 95 days after the revision surgery.¿.

• Brand Name: UNKNOWN EASYCLIP STAPLE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10130582
• MDR Text Key: 194471727
• Report Number: 0008031020-2020-01551
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2020

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 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
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/08/2020
• 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