MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ANCHORAGE CP PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of nonunion and breakage of the implant 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 a literature published by the ¿trauma and orthopaedics department, (b)(6) university hospitals nhs foundation trust, united kingdom¿.The title of this report is ¿risk factors for nonunion after first metatarsophalangeal joint arthrodesis with a dorsal locking plate and compression screw construct: correction of hallux valgus is key¿, published on may 10, 2021.Which is associated with the stryker ¿anchorage plating system¿.The article can be found at https://doi.Org/10.1053/j.Jfas.2020.12.007.This report includes an analysis of the clinical data that was collected on 165 patients.The cases in this study range from (b)(6) 2014 and (b)(6) 2019.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced nonunion and breakage of the arthrodesis anchorage cp plate.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of nonunion and breakage of the arthrodesis anchorage cp plate could be confirmed from the available information and x-ray in the literature study.From the available radiographs, we can see good initial positioning of the device in this mtp i arthrodesis was observed at 3 months postoperatively.In that respect, the patient was treated well technically.Radiographs confirm an implant breakage somewhere between 3-5 months postoperatively.We do not have any clinical information for the individual patient, especially not on the fact if this patient had the risk factors for delayed/nonunion including, but not limited to diabetes, smoking, or poor bone quality.In the case of non-union, the osteosynthesis material will break eventually.This is not related to the device.More detailed information about the patient medical history, the event circumstances, and medical reports must be available 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 a literature published by the ¿trauma and orthopaedics department, liverpool university hospitals nhs foundation trust, united kingdom ¿.The title of this report is ¿risk factors for nonunion after first metatarsophalangeal joint arthrodesis with a dorsal locking plate and compression screw construct: correction of hallux valgus is key ¿, published on may 10, 2021.Which is associated with the stryker ¿anchorage plating system ¿.The article can be found at https://doi.Org/10.1053/j.Jfas.2020.12.007.This report includes an analysis of the clinical data that was collected on 165 patients.The cases in this study range from april 2014 and april 2019.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced nonunion and breakage of the arthrodesis anchorage cp plate.

• Brand Name: UNKNOWN ANCHORAGE CP PLATE
• Type of Device: PLATE, 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: 15060257
• MDR Text Key: 296209289
• Report Number: 0008031020-2022-00348
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

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?: Yes
• 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: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/13/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Female