MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN INSTRUMENT KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNK_SEL

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  Injury  

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.Item was missing in kit.Nothing to return.

Event Description

A loaner was shipped to the hospital for a planned hoffmann lrf surgery.Only 1 of the 2 kits of "bel-hlrf-inst-comp-1" was present at the hospital.The other kit was still at the kit room in zaventem.Issue noticed during kit inspection.Before the start of the surgery.After the patient was already asleep.The patient was reawakened after 30 minutes, and the procedure was postponed until 10-oct.Therefore, secondary anesthetic for the patient.Time loss for the surgeon and or.

Event Description

A loaner was shipped to the hospital for a planned hoffmann lrf surgery.Only 1 of the 2 kits of "bel-hlrf-inst-comp-1" was present at the hospital.The other kit was still at the kit room in zaventem.Issue noticed during kit inspection.Before the start of the surgery.After the patient was already asleep.The patient was reawakened after 30 minutes, and the procedure was postponed until (b)(6).Therefore, secondary anesthetic for the patient.Time loss for the surgeon and or.

Manufacturer Narrative

Please note the corrections to h6 results and h6 conclusion codes.It where reported that one of the kits booked wasn¿t delivered as planned.As a consequence, the surgery was canceled.Distribution opened an nc for investigation of this matter.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.

Manufacturer Narrative

Correction - please refer to h6 health impact code.

Event Description

A loaner was shipped to the hospital for a planned hoffmann lrf surgery.Only 1 of the 2 kits of "bel-hlrf-inst-comp-1" was present at the hospital.The other kit was still at the kit room in zaventem.Issue noticed during kit inspection.Before the start of the surgery.After the patient was already asleep.The patient was reawakened after 30 minutes, and the procedure was postponed until 10-oct.Therefore, secondary anesthetic for the patient.Time loss for the surgeon and operating room.

• Brand Name: UNKNOWN HOFFMANN INSTRUMENT KIT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15677522
• MDR Text Key: 302472566
• Report Number: 0008031020-2022-00564
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 03/20/2023
• Supplement Dates FDA Received: 12/15/2022; 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other