MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Catalog Number 04.214.110S

Device Problems Device Slipped (1584); Defective Device (2588)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent open reduction/internal fixation of the intermediate phalanges.During the surgery, when the surgeon attached the screw in question to the screwdriver, the screw was loose more than other screws and could not be tightened properly.Therefore, the surgeon used a different size of screw instead.The surgery was completed successfully with a 30-minute delay and there was no problem with bone fixation.The patient was reported as stable.No further information is available.This report involves one 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 10mm.This is report 1 of 1 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Additional device product codes: hrs.Initial reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.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 cortscr ø1.5 self-tap l10 tan was heavily worn from the drive recess, most likely due to exposure to unintended forces while handling.Damaged device upon receipt cannot be confirmed since it was not returned in its original and sealed package.A dimensional inspection and a functional test for the cortscr ø1.5 self-tap l10 tan were unable to be performed due to post manufacturing damage and mating device not being returned.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 cortscr ø1.5 self-tap l10 tan 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Type of Device: SCREW, FIXATION, 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: 15631301
• MDR Text Key: 306910741
• Report Number: 8030965-2022-08406
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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: 04.214.110S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK SCREWDRIVER