MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 413.030S

Device Problem Crack (1135)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Picture review: narrative peeled screw thread couldn't be verified from the provided picture.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during the proximal humerus fixation plate removal procedure, eight (8) locking screws' head threads peeled.Surgeon was not able remove all the screws due to peeled screw heads.Surgeon finally broke the plate to remove all the screws.The surgery was delayed more than several hours.The surgery was successfully completed.Patient outcome is reported as stable.This report is for one (1) 3.5mm ti locking screw self-tapping 30mm.This is report 2 of 9 for complaint (b)(4).

Event Description

Additional event information: this is a common practice in mainland china that the trauma surgery requires removal of implants when the bone fracture was already healed.

Manufacturer Narrative

Product complaint # (b)(4) 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.B5: updated additional event information.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: 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11609065
• MDR Text Key: 245900365
• Report Number: 8030965-2021-02556
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819268609
• UDI-Public: (01)07611819268609
• Combination Product (y/n): N
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.030S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; UNK - PLATES: PROXIMAL HUMERAL