MAUDE Adverse Event Report: SYNTHES GMBH CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4; PLATE, BONE

Catalog Number 400.834.04S

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in china as follows: screw breakage.This case is from the health authority.It was reported on (b)(6) 2023, that during the surgery, the tip of one of the screws was broken by 2mm on a peek titanium plate, and the broken part remains inside the plate and cannot be removed.Another location is selected for fixation.The titanium plate with the broken screw was placed in the patient, and the remaining broken screw is retained.A total of 7 screws of the same model and lot number were used in this surgery, and one screw was broken.There was a surgical delay related to the reported event.The surgery was successfully completed.The patient's status or outcome is normal.This report is for one (1) cranial-scr plusdrive ø1.6 self-drill l4 this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16961327
• MDR Text Key: 315864195
• Report Number: 8030965-2023-06367
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819806511
• UDI-Public: (01)07611819806511
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Catalogue Number: 400.834.04S
• Device Lot Number: 2686P51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PEEK IMPLANT
• Patient Age: 43 YR
• Patient Sex: Female