MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI MULTILOC SCREW LENGTH 28MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.019.028S

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  

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) 4.5mm ti multiloc screw length 28mm-sterile.This is report 8 of 9 for (b)(4).

Manufacturer Narrative

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.

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.H4, h6: a device history record (dhr) review was conducted: product code: 04.019.028s, lot number: 68p0606, manufacturing site: grenchen, release to warehouse date: 08.09.2020, expiry date: 01.08.2030.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.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 28MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13176267
• MDR Text Key: 287551502
• Report Number: 8030965-2022-00134
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819430587
• UDI-Public: (01)07611819430587
• 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: 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: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.028S
• Device Lot Number: 68P0606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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