MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 16MM.; SCREW, FIXATION, BONE

Catalog Number 404.816S

Device Problem Material Deformation (2976)

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

Event Date 08/25/2022

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.Procode: hrs.Device available for evaluation: 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

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to implant the device.After that, on (b)(6) 2022, the patient underwent a removal surgery.In the removal surgery, the screw broke at its neck when the surgeon turned it.After that, the surgeon scraped around the screw shaft with a k-wire and extracted it by using radio pliers, etc.It was confirmed that there was nothing left in the patient¿s body.The patient was reported as stable.This report involves one 3.5mm ti cortex screw self-tapping 16mm.This is report 3 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.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 there was no damage or defects with the cortscr ø3.5 self-tap l16 ti, p/n: 404.816s.A dimensional inspection as unable to be performed due to the complex geometry of the device.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 cortscr ø3.5 self-tap l16 ti, p/n: 404.816s was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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, h4, h6: a device history record (dhr) review was conducted: part #: 404.816s, lot #: 387p743, manufacturing site: jabil grenchen, release to warehouse date: 29, september 2021, expiry date: 01, september 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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 procedure was successfully completed and there was no surgical delay.

• Brand Name: 3.5MM TI CORTEX SCREW SELF-TAPPING 16MM.
• Type of Device: SCREW, FIXATION, BONE
• 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: 15454033
• MDR Text Key: 306207003
• Report Number: 8030965-2022-06973
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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: 404.816S
• Device Lot Number: 387P743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø3.5 SELF-TAP L16 TI; CORTSCR Ø3.5 SELF-TAP L26 TI; LCP LAT-DIST-FIBULA PL-2.7/3.5 4HO L86 R; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L12 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L12 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L14 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L14 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L16 TA; LOCKSCR Ø3.5 SELF-TAP L16 TAN