MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL SHT D13XL170; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1317S
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after anesthesia it was found that the implant had not been delivered, and anesthesia time was prolonged until the implant was delivered.Two and a half hours later, the surgery began.Additional info: the implants were not ready at the start of surgery due to an ordering error by the sales rep.The surgery time was extended, but there was no additional anesthesia.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
Please note the correction to h6 conclusion code.The reported event could be confirmed, since it was stated "no defects in product" and further, it was confirmed to be wrongly ordered.As per further details received in the event description ¿¿the implants were not ready at the start of surgery due to an ordering error by the sales rep.The surgery time was extended, but there was no additional an anesthesia¿¿.However, the ifu instructs to check before surgery and clearly points out as a pre-operative step as following: ¿ensure that all components needed for the operation are available in the operation theatre¿.Thus, it has been classified as user-customer-deviation from surgical technique.If this had been checked prior to the start of surgery, it would have been noticed at that time, when the patient was not yet under anesthesia, and consequently would not have led to the start of surgery without having the required implant available and finally not resulted in a prolongation of the surgical procedure due to missing implant [contributed by order error].Thus, it is clearly beyond the manufacturers control and finally, it was confirmed that no defects in product are present.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that after anesthesia it was found that the implant had not been delivered, and anesthesia time was prolonged until the implant was delivered.Two and a half hours later, the surgery began.Additional info: the implants were not ready at the start of surgery due to an ordering error by the sales rep.The surgery time was extended, but there was no additional anesthesia.

• Brand Name: T2 FE RETRO NAIL SHT D13XL170
• 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: 15724344
• Report Number: 0009610622-2022-00483
• Device Sequence Number: 7251566
• Product Code: HSB
• UDI-Device Identifier: 07613327293326
• UDI-Public: 07613327293326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2339-1317S
• Device Catalogue Number: 23391317S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/17/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Female