MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM; SCREW, FIXATION, BONE

Catalog Number 04.210.116

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrs.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 that on (b)(6) 2019 the patient underwent a distal radius surgery with a 2.4mm variable angle-locking compression plate (va-lcp) two-column plate and 2.4mm va locking screws.During the procedure, while exchanging a 2.4mm va-lcp screw, a small metallic splint was formed at the screw head.This splint was formed during removal of the screw.There were no patient consequences reported.Procedure was completed without any other complications.Patient outcome is unknown.Concomitant device reported: unknown 2.4mm va-lcp plate ( part# :unknown, lot#: unknown, quantity 1).This report is for one (1) 2.4mm ti va locking screw stardrive 16mm this is report 1 of 1 for complaint (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.The device was received, additional investigation is in progress, no conclusion could be drawn at the time of filing this report.Picture review: narrative (metal chip on screw head) could be verified from provided pictures.Based on the information available, it has been determined that no corrective and/or preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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

Product complaint # (b)(4).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.Investigation summary picture review: narrative metal chip on screw head) could be verified from provided pictures.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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,investigation site: cq zuchwil selected flow(s): damaged: visual | examples: deformed/bent/cracked/broken visual inspection: upon visual inspection of the complaint device it can be seen that the head thread of the locking screw is damaged (deformed, peeled), this thus confirming the complaint description.Based on the damage the coating is scraped and faded.In addition, the tip of the screw has some discoloration from use.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage and as no lot number got reported.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Based on the received information a review of the technique guide could be performed, further ¿document/specification review¿ is not possible, as no lot number got reported.Summary: based on the received information we cannot determine the exact cause of this complaint.However, we can only assume that the screw was not correctly aligned and came excessively in contact with the plate during insertion.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.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: 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8976549
• MDR Text Key: 156982486
• Report Number: 8030965-2019-68118
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819980235
• UDI-Public: (01)07611819980235
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.210.116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2019
• Date Manufacturer Received: 10/30/2019
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - PLATES