MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN; IMPLANT

Catalog Number UNK_KIE

Device Problems Device Expiration Issue (1216); Expiration Date Error (2528)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

All reported implants were classified as primary products.The two events were reported, event #1: an expired t2 recon set screw was implanted and event #2: two locking screws were explanted from a right tibia, one tibia nail was explanted from the left tibia and one femur nail was explanted from the left femur.Regarding event #1: no deviations were found during review of the manufacturing and inspection documents (dhr).The set screw was documented as faultless prior to distribution.The reported event #1 was confirmed; the dhr review revealed that the set screw got expired at 31.12.2014 and was implanted in (b)(6) 2016, approx.One year after expiration.Real aging tests performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than one year overdue and considered still sterile subsequently.A consultant hcp stated in a similar case that a risk for the patient is not to be expected.The expiry date is a theoretical date which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible.Therefore a relationship between the expired implant and the reported infectious disease is very unlikely and can be excluded based on the given data.The ifu contains that every sterile implant shall be checked prior the surgery; in case the sterility is expired the implant must be re-sterilized.Anyway, since the set screw was on consignment at the time of surgery, the distribution center is responsible for the exceeded expiry date which should have been noticed prior to surgery.Evaluation indicates the event being an error on part of the distribution center.The principal engineer, quality distribution and field ops (stryker (b)(4), usa) was informed about the case in order to address the issue.Regarding event #2: an inspection and a review of the manufacturing and inspection documents (dhr) were not possible because neither the implants, nor the product identification details (cat#, lot#) were provided.The provided information indicates that two screws and three nails were explanted from a right and left tibia and a left femur due to a non-healed fracture (non-union) during a planned revision surgery; implant damages were not reported.It can be assumed that the implants did not fail postoperatively and functioned like specified.Non-unions can have several reasons, i.E.: poor bone quality, poor fracture repositioning, kind of postoperatively mobilization, poor or no blood supply.All these effects are listed as adverse effects in the ifu and can lead to implant damages.Because no implant damage was reported a relationship between the explanted implants and the non-union can be excluded based on the given information.No non-conformity identified.Device disposition is unknown.

Event Description

User facility report was received from the fda # (b)(4).Event # 1: outdated orthopedic hardware implanted during surgery.Hardware expired 12/2014 and sterilization date was 1/2010.This was noticed after it was implanted.Ingection control will be monitoring patient and infectious disease was notified.Event # 2: what was the original intended procedure: removal of proximal and distal locking bolts of the right tibia, removal of im nail in the left femur as well as exchange nailing of the left femur, removal of the tibial im nail with exchange nailing of the left tibia.The revision was planned, there was nonunion of the fracture and the patient elected to have a re-do.

• Brand Name: UNKNOWN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5545707
• MDR Text Key: 41824514
• Report Number: 0009610622-2016-00180
• Device Sequence Number: 1
• Product Code: HSB
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• 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: 38 YR