MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SELF-TAPPING 40MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 213.040S

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h6: 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

Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent femoral subtraction osteotomy with php implant.All screws used in the procedure were locking screws, and torque limiting was applied to them.After the surgery, screws in proximal ventral side were loose.On (b)(6) 2024 all implants were removed, and then a new plate and screws were inserted.When the first plate and screws in question were removed, the surgeon did not notice the feeling of unlocking the three proximal side screws.Therefore, it was assumed that all screws in the proximal side were likely loose.No further information is available to report.This report is for a 3.5mm locking screw self-tapping 40mm.This is report 2 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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A manufacturing record evaluation was performed for the finished device product code: 213.040s.Lot number# 214p339.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on 23-jun-2021.Manufacturing site: jabil grenchen.Expiry date: 01-jun-2031.Photos were provided for review, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The lockscr ã¸3.5 self-tap l40 sst has evidence of normal use.Functionality issues cannot be assessed through a photo investigation.The overall complaint was not confirmed for lockscr ã¸3.5 self-tap l40 sst.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.G1: manufacturing site name & address corrected.H4: device manufacture date corrected.

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 there were no damage or defect with the lockscr ã¸3.5 self-tap l40 sst.Per the surgical technique guide, ¿note: do not fully insert the locking screws by power.Always perform final tightening by hand using the screwdriver handle, torque limiting attachment and screwdriver shaft.The screw is securely locked to the plate when a click is heard.¿ a dimensional inspection for the lockscr ã¸3.5 self-tap l40 sst was not performed as it is not applicable to reported condition.A functional test was performed with the mating device (lcp paed-hippl 3.5 120° w/19 l75) and the screw was able to lock in each locking hole.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 not confirmed as the observed condition of the lockscr ã¸3.5 self-tap l40 sst would not 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: 3.5MM LOCKING SCREW SELF-TAPPING 40MM
• 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): JABIL GRENCHEN; solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18730386
• MDR Text Key: 336753777
• Report Number: 8030965-2024-02614
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000684
• 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: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213.040S
• Device Lot Number: 214P339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LCP PAED-HIPPL 3.5 120° W/19 L75; LCP PAED-HIPPL 3.5 120° W/19 L75; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING