MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT HN Ø7 CANN L210 TAN; NAIL, FIXATION,BONE

Catalog Number 04.001.222S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2019

Event Type  malfunction  

Manufacturer Narrative

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 at an unknown date, the doctor was trying to place the nail with the respective connection screw to fix it before implanting it, the doctor indicates that he cannot connect the nail with the connection screw even when he was doing it correctly.The doctor states that the nail came with the damaged thread.No patient affected.Concomitant device reported: unknown connection screw (part # unknown, lot # unknown, quantity unknown), unknown insertion handle (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the complaint device was not received for investigation.The following investigation is based on the image(s) provided image(s) was reviewed, and the complaint condition is confirmed since the thread appears torn or stripped and would block devices assembling to the screw.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: EXPERT HN Ø7 CANN L210 TAN
• Type of Device: NAIL, FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9285745
• MDR Text Key: 196262545
• Report Number: 8030965-2019-70016
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819782792
• UDI-Public: (01)07611819782792
• Combination Product (y/n): N
• PMA/PMN Number: K033071
• 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: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.001.222S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/15/2019
• Patient Sequence Number: 1