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

Catalog Number 314.116

Device Problem Material Deformation (2976)

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

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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 (b)(6) 2020, the patient underwent a surgery treating the proximal tibia.After surgery, on (b)(6) 2022, the patient underwent a removal surgery of implants.In the removal surgery, 1 of the 4 screws was crimped and stuck, the surgeon decided to use the drill bit to remove the screw.The surgeon could not remove the screw because the screw stuck so firmly, and the drill bit became shaved when it was applied to remove the screw.The tip of the driver shaft was also deformed, making it difficult to remove the screw.Therefore, the surgeon used a carbide drill bit instead of the drill bit and managed to remove the screw.The surgery was completed successfully within 30 minutes delay.This report involves one (1) stardrive screwdriver shaft qc/t15.This is report 2 of 3 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H10 additional narrative: h3, h6: a product investigation was conducted.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 tip of the scrdriver shaft 3.5 t15 self-hold f/ao/a was twisted.No other product defect was observed.A dimensional inspection was performed for the scrdriver shaft 3.5 t15 self-hold f/ao/a and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.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.H3, h6: a device history record (dhr) review was conducted: part #: 314.116, lot #: h753590, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 12 june 2019, expiration date: n/a.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.After further review, it was determined the screwdriver did not contribute to an adverse event and the malfunctioned the device experienced is has not, and is not likely to, contribute to an adverse event if it were to recur.

• 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: 13975689
• MDR Text Key: 288361933
• Report Number: 8030965-2022-02096
• 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
• Type of Report: Initial,Followup,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: H753590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/08/2022; 04/27/2022; 06/17/2022
• Supplement Dates FDA Received: 04/12/2022; 04/29/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CARBIDE DRILL BIT Ø4 F/INSTR STEEL+TI.; HSS DRILL BIT Ø2.5 F/IMPLANT STEEL.; UNK - SCREWS: 3.5 MM CORTEX.
• Patient Outcome(s): Required Intervention