MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 65MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 413.365S

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent an open wedge distal tuberosity osteotomy with the locking screws in question for the tibia.The surgery was completed successfully without any surgical delay.Two weeks after the surgery, the patient had 30% loading.Three weeks after the surgery, the patient had full loading.On (b)(6) 2022, it was confirmed that bone healing was not achieved, and it was also confirmed that the four locking screws were broken from the screwhead part.In addition, the patient was infected.Therefore, a revision surgery was scheduled for (b)(6) 2022.The implants were removed, and debridement was performed.No further information is available.This report involves one 5.0mm ti locking head screw self-tapping 65mm.This is report 3 of 4 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.Additional narrative: only the event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Reoperation was performed on (b)(6) 2022 to remove implants, treat for debridement, and external fixation.The patient status was reported to be stable after the revision surgery.

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: 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 lockscr ø5 self-tap l65 tan was found thee screw head broken.Broken fragment was returned.Screw head still stuck on the mating device tomofixtibheadpl anatom med prox le he 4.A dimensional inspection for the lockscr ø5 self-tap l65 tan 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 lockscr ø5 self-tap l65 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a device history lot part number: 413.365s, lot number: 560p324, manufacturing site: grenchen, release to warehouse date: 21 december 2021, expiry date: 01 december 2031.A manufacturing record evaluation was performed for the finished device lot, 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.

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 65MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15615707
• MDR Text Key: 301842520
• Report Number: 8030965-2022-08253
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023941
• 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

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.365S
• Device Lot Number: 560P324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 SELF-TAP L60 TAN; LOCKSCR Ø5 SELF-TAP L65 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG