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

Catalog Number 400.834

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/31/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in china as follows: it was reported that on (b)(6) 2022, that when the equipment department of the hospital inspected the device, it noted 5 self drilling screws could not drill.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) cranial-scr plusdrive ø1.6 self-drill l4.This is report 1 of 5 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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(6) hospital.(b)(6).Reporter is a j&j employee.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary: both a photo of the device and the actual device were received for evaluation.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment (b)(4).Visual analysis of the photo revealed that the cranial-scr plusdrive ø1.6 self-drill l4 had no damages or product defects from the provided image.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the cranial-scr plusdrive ø1.6 self-drill l4 had the edges of the threads screw worn, the distal tip was noted damaged and the shaft bent.The device was observed with white unknown particles attached along the shaft and presents dents, these conditions mostly can be caused by usage / attempted, hard bone or misalignment of the screw during the procedure and cannot be traced to a manufacturing issue.A dimensional inspection for the cranial-scr plusdrive ø1.6 self-drill l4 was unable to be performed due to post manufacturing damage.A functional test was unable to be performed since the functionality of the screw cannot be tested with tools.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the cranial-scr plusdrive ø1.6 self-drill l4 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review : part number: 400.834, lot number: 149p092: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.

• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14836251
• MDR Text Key: 301761036
• Report Number: 8030965-2022-04388
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819753457
• UDI-Public: (01)07611819753457
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Lot Number: 149P092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1