MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Catalog Number	657014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Implant Pain (4561)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had surgery on (b)(6) 2018 to insert a clavicle plate and screws.Patient went back 2-days post-op because he was experiencing a lot of pain.Received a call from anesthesiologist to follow up, patient mentioned pain in his jaw and ear.Maintains that there might have been damage to his throat when removing the intubation tube.Went to see orthopedic doctor for follow up a week later for suture removal and when bandages were removed it was noticed that it did not look normal.Patient had hardware and 9 screws inserted and now has a bump sticking out in his clavicle and has been having problem ever since.He is experiencing pain and limited range of motion.Cannot really use his left arm and is experiencing hip pain.When in hot weather he needs to cover up the implant because it gets hot and it hurts when the weather is cold.He claims that the surgery is botched.Hardware has not been removed at this moment.
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.H3 other text : device remains implanted.

• Brand Name: LOCKING SCREW, T10 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18357110
• Report Number: 0008031020-2023-00436
• Device Sequence Number: 6885889
• Product Code: HWC
• UDI-Device Identifier: 07613327069266
• UDI-Public: 07613327069266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 657014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 52 KG