MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN; PIN, FIXATION, THREADED

Catalog Number UNK_SEL

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Unspecified Infection (1930)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of orthopaedics and traumatology, queen elizabeth hospital, hong kong¿.The article can be found at https://doi.Org/10.1177/2309499019833897. the reported event 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's medical history, the event details and the involved device(s) 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 ¿department of orthopaedics and traumatology, queen elizabeth hospital, hong kong¿.The title of this report is, ¿three-dimensional-guided navigation percutaneous screw fixation of fragility fractures of the pelvis¿, published on march 12, 2019, which is associated with the stryker ¿apex pin system¿.The article can be found at https://doi.Org/10.1177/2309499019833897.This report includes an analysis of the clinical data that was collected on 17 patients, and the cases in this study range from 2016 to 2017.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced pin tract infection requiring debridement, antibiotics and premature removal of the loosened external fixator.The report states, ¿unfortunately, an infection of the iliac crest pin tract developed requiring debridement, antibiotics and premature removal of the loosened external fixator.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of pin tract infection requiring debridement, antibiotics and premature removal of the loosened external fixator could not be confirmed, from the available information in the literature.Based on the available x-ray a formal medical opinion was sought in which it is stated that: it is very hard to judge what happened, it is also unclear how stable the external fixator was build.It is debatable whether this patient got the right treatment in the first place.The external fixation device is additional fixation for additional stability.Since there is no medical record available the infection cannot be directly confirmed.However, the authors describe that it happened like that.Pin tract infections a very common for external fixators, so it is not unlikely that this occurred.If the external fixator pin indeed loosened due to the infection, the stability of the entire construct was in danger and no longer helpful for the purpose it was used.Removing the ex-fix makes sense if it does not provide the needed additional stability anymore, because the infection might become worse if the ex-fix stays in place, this may further endanger the patient.Based on the available information and formal expert opinion the root cause cannot be given since there is to little information given in the article.More detailed information will be required in order to determine the definitive 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 ¿department of orthopaedics and traumatology, queen elizabeth hospital, hong kong¿.The title of this report is, ¿three-dimensional-guided navigation percutaneous screw fixation of fragility fractures of the pelvis¿, published on march 12, 2019, which is associated with the stryker ¿apex pin system¿.The article can be found at https://doi.Org/10.1177/2309499019833897.This report includes an analysis of the clinical data that was collected on 17 patients, and the cases in this study range from 2016 to 2017.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced pin tract infection requiring debridement, antibiotics and premature removal of the loosened external fixator.The report states, ¿unfortunately, an infection of the iliac crest pin tract developed requiring debridement, antibiotics and premature removal of the loosened external fixator.¿.

• Brand Name: UNKNOWN APEX PIN
• Type of Device: PIN, FIXATION, THREADED
• 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: 15735806
• MDR Text Key: 303085175
• Report Number: 0008031020-2022-00572
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Date Manufacturer Received: 12/21/2022
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female