MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-1134S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: "the nail was implanted on (b)(6) 2015.It is a stryker tibial nail t2 stryker, 345 mm, size 11.Postoperatively, the patient initially underwent partial weight-bearing for 2 weeks and then full weight-bearing depending on the degree of discomfort.The patient was followed up regularly by the surgeon in consultation.The metal removal took place on (b)(6) 2021.All locking pins were removed there - but the nail could not be taken out despite intensive efforts.The nail bothered the patient after 6 1/2 years and he wanted to have it removed.The nail could not be removed during the four-hour surgery, which upset the patient very much.The customer suspects that the nail bent in the lower part and therefore could not be removed.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The reported event indicated that the implants had fulfilled their tasks ¿ temporary stabilization of a bone fracture ¿ for a period of 6.5 year[s].The course of bone healing has not been provided and no indication is given that the patient has fallen.The reported event is about unsuccessful hardware removal, and no revision was carried out.As per ifu ¿the implant is intended for temporary bone fixation, if explantation is not carried out, complications may occur.¿ in many instances adverse effects are rather clinical than device related.Furthermore, it is pointed out as following ¿the surgeon must counsel each patient individually on correct behavior and activity after the implantation.¿ whether the patient was affected by any unusual changes and / or accidents in the implantation area was unknown.Medical records and x-ray images were requested but to no avail and thus, a medical statement was not possible.According to details available no deviation in contouring of the nail was reported at the time of nail implantation.Used counterparts for metal removal procedure [extraction tools] were unknown.The brochure "implant extraction set optech¿ offers guidance how to proceed during implant explantation and describes the handling with the different counterparts.With details given no discrepancies of the nail in question was verified and a further technical statement was impossible.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.No hint of indications of material, manufacturing or design related problems could be verified based on current information available.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "the nail was implanted on (b)(6) 2015.It is a stryker tibial nail t2 stryker, 345 mm, size 11.Postoperatively, the patient initially underwent partial weight-bearing for 2 weeks and then full weight-bearing depending on the degree of discomfort.The patient was followed up regularly by the surgeon in consultation.The metal removal took place on (b)(6) 2021.All locking pins were removed there but the nail could not be taken out despite intensive efforts.The nail bothered the patient after 6 1/2 years and he wanted to have it removed.The nail could not be removed during the four-hour surgery, which upset the patient very much.The customer suspects that the nail bent in the lower part and therefore could not be removed.".

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13737018
• Report Number: 0009610622-2022-00089
• Device Sequence Number: 4737294
• Product Code: HSB
• UDI-Device Identifier: 04546540198044
• UDI-Public: 04546540198044
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1822-1134S
• Device Catalogue Number: 18221134S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male