MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREWS, CROSS-PIN, DIAM.2.3X20MM, (5/PACKAGE); PLATE, FIXATION, BONE

Model Number	52-23620
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: on (b)(6) 2020, the patient fell down on a bicycle which lead to right wrist suffered stress, and immediately the distal end of the right forearm was deformed and the pain was severe.According to ct inspection, the patient was diagnosed right distal radius fracture and ulnar styloid fracture by the second hospital (b)(6).On (b)(6) 2020, patient came to (b)(6) hospital, and requested surgery for further treatment.The patient was diagnosed two issues by (b)(6) hospital.One is right distal radius fracture and ulnar styloid fracture.The other one is diabetes.On (b)(6) 2020, patient was performed reduction internal fixation surgery under intravenous anesthesia and nerve block descending.During medical operation, when the nine cross-head locking screws were screwed in, one of screws (part number 52-23620s) was slipped.It can¿t be screw into plate.The surgeon felt that the screw thread of this screw was not match with plate.A same specification and lot replacement was used to screw in plate.Surgeon used the same hole on the plate with another screw successfully.C-arm fluoroscopy showed that the broken part was in good alignment.Gypsum external fixation was performed.Finally, the medical procedure was completed successfully.On (b)(6) 2021, patient discharged from (b)(6) hospital.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.During the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.¿ 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.However, as per the additional information provided one of the probable causes of this event is not using the stryker instrument (screwdriver) for the screw insertion.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: on (b)(6) 2020, the patient fell down on a bicycle which lead to right wrist suffered stress, and immediately the distal end of the right forearm was deformed and the pain was severe.According to ct inspection, the patient was diagnosed right distal radius fracture and ulnar styloid fracture by the second hospital of hai shu district.On (b)(6) 2020, patient came to the sixth of (b)(6) hospital, and requested surgery for further treatment.The patient was diagnosed two issues by the sixth of (b)(6) hospital.One is right distal radius fracture and ulnar styloid fracture.The other one is diabetes.On (b)(6) 2020, patient was performed reduction internal fixation surgery under intravenous anesthesia and nerve block descending.During medical operation, when the nine cross-head locking screws were screwed in, one of screws(part number 52-23620s ) was slipped.It can¿t be screw into plate.The surgeon felt that the screw thread of this screw was not match with plate.A same specification and lot replacement was used to screw in plate.Surgeon used the same hole on the plate with another screw successfully.C-arm fluoroscopy showed that the broken part was in good alignment.Gypsum external fixation was performed.Finally, the medical procedure was completed successfully.On (b)(6) 2021, patient discharged from the sixth of (b)(6) hospital.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.3X20MM, (5/PACKAGE)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11225500
• Report Number: 0008031020-2021-00028
• Device Sequence Number: 3512950
• Product Code: HRS
• UDI-Device Identifier: 37613153067994
• UDI-Public: 37613153067994
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 52-23620
• Device Catalogue Number: 52-23620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR