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 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 evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) medical campus ((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.5 out of 15 cases.The report states, ¿subject (b)(6) was a (b)(6) male (other race) who had a fall from height.Subject injured his right talus (open fracture) and right medial malleolus (open fracture).A stryker external fixator with 5 apex pins was placed on the right ankle for temporary stabilization and complex wound closure of the right ankle (10 cm) was performed.Subject also had a l3 vertebral body fracture, current tobacco use.Was discharged on pod #3, non-weightbearing.Thirteen days after external fixator placement, the subject was seen in the clinic and presented with drainage around pin sites with erythema about the dorsum of the foot.Antibiotics were prescribed for seven days.Subject had been previously placed on antibiotics while at acute rehabilitation for suspected cellulitis.Subject was twenty two days out from external fixator placement, when he returned to the clinic and had a ¿little touch¿ of serous drainage from the pin sites.Antibiotics were re-prescribed for a ¿very low grade pin site infection.¿ at thirty three days post external fixation placement, clinic visit notes state subject is finishing up antibiotic prescription, wounds are all healed.The external fixator was removed in the clinic, 47 days after placement.¿.

• 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: 8704883
• MDR Text Key: 148269666
• Report Number: 0008031020-2019-00611
• 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: 28 YR