MAUDE Adverse Event Report: STRYKER GMBH L COMPRESSION PROFILE PLATE, T-SHAPE, 90 DEGREES, NARROW, 6 HOLES; PLATE, FIXATION, BONE

Model Number	57-13110
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "on (b)(6) 2015.The patient's left hand was injured by a machine accidentally at home.Finally, doctor diagnosed that patient¿s left thumb and index finger were not completely severed.On (b)(6) 2015 , left hand debridement, thumb replantation, middle finger extensor tendon repair, back of hand avulsion skin repair, foreign body removal, vsd drainage.The medical operation was successfully.Recently, the patient had local protrusion of the proximal segment of the index finger with swelling and pain for more than 20 days.On (b)(6) 2021, patient performed x ray.The image show that proximal index finger was fixed with plate screws after multiple fractures of the left hand.B ultrasonography: screw echo in the proximal radial segment of the left index finger.A plate screw internal fixation was performed to remove a bone screw and a plate." additional information received - 11/08/2021.The patient went to the doctor again on (b)(6) 2021 due to local protrusion and redness of the proximal index finger.The patient has performed revision surgery, the plate had been removed from patient and scrapped by hospital as medical waste.According to the doctor's physical examination and imaging diagnosis, it was inferred that the disease was caused by loosening of implant screws.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported: "on (b)(6), 2015.The patient's left hand was injured by a machine accidentally at home.Finally, doctor diagnosed that patient¿s left thumb and index finger were not completely severed.On (b)(6), 2015 , left hand debridement, thumb replantation, middle finger extensor tendon repair, back of hand avulsion skin repair, foreign body removal, vsd drainage.The medical operation was successfully.Recently, the patient had local protrusion of the proximal segment of the index finger with swelling and pain for more than 20 days.On (b)(6) 2021, patient performed x ray.The image show that proximal index finger was fixed with plate screws after multiple fractures of the left hand.B ultrasonography: screw echo in the proximal radial segment of the left index finger.A plate screw internal fixation was performed to remove a bone screw and a plate." additional information received - (b)(6)/2021 the patient went to the doctor again on (b)(6), 2021 due to local protrusion and redness of the proximal index finger.The patient has performed revision surgery, the plate had been removed from patient and scrapped by hospital as medical waste.According to the doctor's physical examination and imaging diagnosis, it was inferred that the disease was caused by loosening of implant screws.
Additional Manufacturer Narrative
Correction: please refer to d4 catalog#, gtin, h6 results & conclusion codes.A device inspection was not possible since the affected device was not returned.The received pictures and x-ray were reviewed and it can be confirmed that one of the non-locking screws is backed out from the t-shaped plate and does protrude from the plate.It can also be confirmed that the bone healing process is completed, there are no signs from the previous fracture visible.Without the involved devices no further evaluation is possible.A review of the device history for the reported lot did not indicate any abnormalities.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on the provided information were the devices in place for more than 6 years and the bone healing process is completed, therefore it is more than unlikely that any product related issue did lead to the back out of the non-locking screw.In this relation following statement form the instruction for use can be mentioned: [screw and plate implants are designed to function only until bone healing (usually 6-10 weeks).Delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or fracturing.] [original statements].

• Brand Name: L COMPRESSION PROFILE PLATE, T-SHAPE, 90 DEGREES, NARROW, 6 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12867704
• Report Number: 0008031020-2021-00476
• Device Sequence Number: 6025479
• Product Code: HRS
• UDI-Device Identifier: 04546540243164
• UDI-Public: 04546540243164
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062498
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 57-13110
• Device Catalogue Number: 57-13140
• Device Lot Number: 1000128102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 79 KG