MAUDE Adverse Event Report: SYNTHES GMBH TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.019.000S

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of proximal end of left humerus.The surgery was completed successfully without any surgical delay.After the surgery, on (b)(6) 2021, it was confirmed that reduction position had collapsed, and bone fragments had fallen out of the implants.The cause of this event is unknown, and the removal surgery of the implants will be performed on (b)(6) 2021.No further information is available.This report is for one (1) ti multiloc end cap f/multiloc nail/0mm extension-sterile.This is report 4 of 9 for (b)(4).

• Brand Name: TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13175922
• MDR Text Key: 287025042
• Report Number: 8030965-2022-00128
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.000S
• Device Lot Number: 329P776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 02/16/2022
• 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: CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI; LOCKSCR Ø3.5 SELF-TAP L26 TAN; LOCKSCR Ø3.5 SELF-TAP L28 TAN; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; PHN MULTILOC Ø9.5 IZQ CAN L160 TAN; TORNILLO MULTILOC Ø4.5 L26 TAN; TORNILLO MULTILOC Ø4.5 L28 TAN; TORNILLO MULTILOC Ø4.5 L28 TAN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female