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Catalog Number UNK_KIE
Device Problem Device Expiration Issue (1216)
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)) 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 number, lot number) 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. Infection 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.
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Type of DeviceIMPLANT
Manufacturer (Section D)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
MDR Report Key5545837
MDR Text Key41823231
Report Number0009610622-2016-00184
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2016
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 Treatment Data
Date Received: 04/04/2016 Patient Sequence Number: 1