MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER SHAFT QC/T15

Catalog Number 314.116

Device Problem Scratched Material (3020)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is j&j company representative 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.No code available is for injury; it is not known if fragments remained behind in the patient.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in (b)(6) 2015, the patient underwent the surgery with a philos implants.The surgery was completed successfully without any surgical delay.After the surgery, removal surgery was performed on (b)(6) 2022, due to unknown reason.In the removal surgery, it was difficult to remove the locking screw and chipped the tip of the screwdriver shaft.The second screwdriver was used, but this tip was also chipped.The locking screw was removed using a vice grip.The removal surgery was completed successfully without any surgical delay.It is known know if fragments were removed or not.This is report 1 of 3 for (b)(4).This report is for a screwdriver shaft.

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.H3, h4, h6: part # 314.116, lot # 6760107, manufacturing site: werk selzach, release to warehouse date: december 12, 2011, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 scrdriver shaft 3.5 t15 self-hold f/ao/a was found broken from the tip, the broken fragment was not returned for evaluation.A dimensional inspection for the scrdriver shaft 3.5 t15 self-hold f/ao/a was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 scrdriver shaft 3.5 t15 self-hold f/ao/a 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 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.

Event Description

The initial complaint was reviewed and found not reportable.Upon review of this product complaint it was identified that the reported information reasonably suggest that this product may not have caused or contributed to a serious injury.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT QC/T15
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14085305
• MDR Text Key: 289099387
• Report Number: 8030965-2022-02376
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819740877
• UDI-Public: (01)07611819740877
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 314.116
• Device Lot Number: 6760107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 06/17/2022
• Supplement Dates FDA Received: 06/06/2022; 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCRDRIVER SHAFT 3.5 T15 SELF-HOLD F/AO/A; UNK - SCREW LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Female