MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 401.063

Device Problem Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: jey.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A dhr review could not be performed for this pi.The lot number is invalid.Please confirm / correct the lot number and resubmit.Product was not returned.Based on the information available, it has been determined that no corrective and 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) 2020, the patient underwent the surgery with the screw.During the screw insertion, the screw was not inserted properly.The surgeon used another screw, and the surgery was completed successfully without any surgical delay.The patient was reported as stable.Concomitant devices reported: screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) 2.0mm ti crtx screw slf-drlg w/plusdrive(tm) recess 6mm.This is report 1 of 1 for (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.H3, h4, h6: part 401.063, lot 11l9192: manufacturing location: monument.Manufacturing date: july 16, 2019.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection of the complaint device it can be seen that the screw tip is slightly worn (blunt) from use.Furthermore, the screw recess is badly deformed/damaged most likely from use (implantation and explantation).Otherwise, the screw is in a good condition.Those signs of use thus confirming the complaint description.Drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture.The complaint is confirmed as the screw is damaged in a way that an appropriate use is not possible.The review of the production history revealed that this item was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Unfortunately, we are not able to determine the exact reason for this occurrence, but it is likely that the damage occurred based on an insufficient connection to the screwdriver or/and that during the operation an application error may have taken place.The cause of complained malfunction is a post-manufacturing caused and/or use related.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 as no product related issue could be detected.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.H11: corrected data: b4/g3: alert date initially reported as august 31, 2020, but should have been september 01, 2020.

• Brand Name: 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10574067
• MDR Text Key: 208157665
• Report Number: 8030965-2020-07354
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819772526
• UDI-Public: (01)07611819772526
• Combination Product (y/n): N
• PMA/PMN Number: K102656
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.063
• Device Lot Number: 11L9192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/04/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS; UNK - SCREWDRIVERS.