MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Discharge (2225)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.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 reviewed ifu, however, states that ¿early or late infection, both deep or superficial¿ is one of the most frequent adverse effects involving the use of internal fracture fixation devices and adverse results may be clinically related rather than device related.Also, the surgeon must warn patients of surgical risks, and make them aware of possible adverse effects.The patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma.Based on the available information, no relation could be established between the device and the reported event.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of fractures with the apex pins in conjunction with stryker external fixation systems¿ which was published in april 2019 and is associated with the stryker apex pin.Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2018.It was not possible to ascertain specific device or patient information from the article, 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 52 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses pin tract infection.7 out of 15 cases.The report states, ¿subject (b)(6) was a (b)(6) caucasian female who was a fall from standing with a tibia fracture.Stryker hoffman 3 external fixator system with 5 stryker apex pins was used originally for temporary placement.Subject endorsed current tobacco use with no additional health history.The subject was discharged home on pod 2 as nonweightbearing on the left lower extremity.When subject returned for her surgical procedure for definitive treatment, it was discovered that she had a deep wound infection which was treated for irrigation and debridement (i&d).During this time the orthopaedist changed the patient¿s fracture treatment management to utilizing the external fixator system for definitive treatment.The subject underwent two additional i&ds for excessive drainage and readjustments of her stryker external fixator system.The subject had two events associated with pin tract infection.The first was at the 5 month post-op follow-up, the subject was provided one week of antibiotics and required the subject to clean pin sites twice a day with peroxide and saline for her ¿mild erythema about the distal pin sites.¿ the subject did not return within one week¿s time to verify if the ¿mild erythema¿ had cleared up.Second occurrence was two months later from the first occurrence, the orthopaedist observed a mildly erythematous with scant amount of drainage at the anterior pins in the foot.The orthopaedist ¿removed the clamps and bars and pins from the anterior foot and placed peroxide deep in the wounds to clean them out.There was some drainage noted after pin removal.Additionally, the orthopaedist noted that the subject was smoking during her definitive treatment with the external fixator system.The external fixator system and pins were removed five days later (210 days from initial surgery) along with antibiotic treatment was provided to the subject.During the subject¿s first post-op visit from removal external fixator system with pins, the orthopaedist noted ¿that there was no evidence of erythema or infection and pin sites were healing".

• Brand Name: UNKNOWN APEX PIN
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8704745
• MDR Text Key: 148268627
• Report Number: 0008031020-2019-00583
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 05/22/2019
• 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: 64 YR