MAUDE Adverse Event Report: SYNTHES GMBH HN MULTILOC Ø7 DCHO CAN L255 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.016.255S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 02/02/2022

Event Type  Injury  

Event Description

Multiloc humeral nail removal due to nail backing out.X2 multiloc screws removed and x1 4mm locking screw (both unknown reference/lot numbers).This complaint involves one(1) device hn multiloc ø7 dcho can l255 tan.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.

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.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.H6: a photo investigation was conducted.The photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that there was no damage or defects with the hn multiloc ø7 dcho can l255 tan.X-ray evidence does not show signs of migration or movement of the nail.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the hn multiloc ø7 dcho can l255 tan.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H6: a device history record (dhr) review was conducted: part: 04.016.255s, lot: 2l98449, manufacturing site: mezzovico, supplier: n/a, release to warehouse date: 25 mar 2019, expiration date: 01 mar 2024.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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: HN MULTILOC Ø7 DCHO CAN L255 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13651323
• MDR Text Key: 286431396
• Report Number: 8030965-2022-01270
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819501119
• UDI-Public: (01)07611819501119
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 04.016.255S
• Device Lot Number: 2L98449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 03/14/2022; 04/26/2022
• Supplement Dates FDA Received: 04/11/2022; 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male