MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Model Number 319.006

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales representative.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date, the four depth gauge sleeves were found after sets had been through decontamination and the inner part of the depth gauge had been disposed of by central sterile staff due to the inner part of the depth gauge being bent or broken.There was no patient involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 2 of 4 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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n: 319.006, lot number: h786310) was received at us cq.Visual inspection of the complaint device showed the slider component was not returned due to being disposed of by central sterile staff.The returned body component had no observed damage.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as the returned part component was not damaged and the other components were disposed of and not missing.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.A device history record (dhr) review was conducted: part # 319.006 synthes lot # h786310 supplier lot # h786310 release to warehouse date: 20 dec 2019 supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11401733
• MDR Text Key: 243402718
• Report Number: 8030965-2021-01530
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: H786310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1