MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM; APPLIANCE, FIXATION, NAIL

Catalog Number 413.024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that patient was being treated for polytrauma, including a fracture of the left humeral paddle with nerve neurolysis ulnar, on (b)(6) 2022.During treatment, surgeon observed the presence of a cutaneous fistula by a previous osteosynthesis of the pallet humerus with oleocranotomy and pin guying to the skin.The surgeon had to remove the osteosynthesis material which had been implanted two years ago.During the operation, a drill bit broke in the patient's bone.The broken piece is not salvageable and was left in place.Procedure was completed successfully with a less than thirty minute delay.This report is for a 3.5mm ti locking screw self-tapping 24mm.This is report 2 of 11 for (b)(4) and captures removal of previously implanted devices.The intraoperative breakage of the drill bit is captured under (b)(4).

• Brand Name: 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14043971
• MDR Text Key: 288802494
• Report Number: 8030965-2022-02261
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819239241
• UDI-Public: (01)07611819239241
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø2.4 SELF-TAP L18 TAN; CORTSCR Ø3.5 SELF-TAP L24 TI; CORTSCR Ø3.5 SELF-TAP L28 TI; DHP 2.7/3.5 DORSO-LAT LE 5HO TI; HSS DRILL BIT Ø3.5 F/IMPLANT STEEL; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L18 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L24 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L28 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L30 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L32 TA; LOCKSCR Ø3.5 SELF-TAP L26 TAN
• Patient Outcome(s): Required Intervention