MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 SCREW DEPTH GAUGE; EXTREMITY INSTRUMENTS : DEPTH GAUGE

Model Number 2307-91-001

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Customer claims that the measure on the depth gauge device does not show the correct measure after checking to a ruler measurement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device found no defect.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 230791001 screw depth gauge.Examination of the returned screw depth gauge found no defect or malfunction of the device.The initial reports states the depth gauge device does not show the correct measure after checking to a ruler measurement.Inspection of all functional dimensions of the printed measurement features of the screw depth gauge were found to meet specifications per dwg-7e070444 rev a.No further observations were made.A search of the worldwide complaint database found no additional complaints related to the current reported event.The investigation could not verify or identify any product contribution to the reported event with the information provided.No evidence was found indicating product error was a contributing factor and no corrective action is being pursued.Monitor complaints through sep-419 depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SCREW DEPTH GAUGE
• Type of Device: EXTREMITY INSTRUMENTS : DEPTH GAUGE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9929517
• MDR Text Key: 190365560
• Report Number: 1818910-2020-10284
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10603295116554
• UDI-Public: 10603295116554
• Combination Product (y/n): N
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-91-001
• Device Catalogue Number: 230791001
• Device Lot Number: 5037274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1