MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HANSSON TWIN HOOK; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Pain (1994); Perforation (2001); Hip Fracture (2349); Non-union Bone Fracture (2369)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported: "in 2017, internal fixation with twin hook was used for femoral neck fracture and t2 nail was used for femoral supracondylar fracture.Four years postoperatively, the appearance of abdominal pain led to pelvic perforation of the hook pin, pseudoarticulation of the femoral neck, and fracture of the distal screw.Revision surgery was performed, the fractured screws were left in the bone and the hook was removed.There was no internal damage.".

• Brand Name: UNKNOWN HANSSON TWIN HOOK
• Type of Device: IMPLANT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12537500
• MDR Text Key: 273530649
• Report Number: 0008031020-2021-00421
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2021

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
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 93