MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET DEPTH GAUGE 70MM; DRILL GUIDES

Catalog Number 227460000

Device Problem Material Deformation (2976)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

This instrument is composed of 1 part.The depth gauge has been bent.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> according to the information received, "this instrument is composed of 1 part.The depth gauge has been bent as per the images attached." the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that the tip of quickset depth gauge 70mm was bent.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the quickset depth gauge 70mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot
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> a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code ag1007 provided is not a valid finished goods lot#.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: this instrument is composed of 1 part.The depth gauge has been bent as per the images attached.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the tip bent in shaft part of quickset depth gauge 70mm, confirming allegation.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.Additionally, corrosions and smeared patterns were observed on device surface, suggesting it happed due to repeated cleaning/sterilization cycles over the 17 years of usage.Potential cause for the bent condition can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Properly handling and attention to the approved use of the device diminishes the risk of failure.Potential cause for both corrosion and smeared condition may be traced to maintenance if cleaning and/or sterilization instructions are not properly followed as ifu-0902-00-721 rev.K indicates.For cleaning instructions, ifu states the following: "prepare an enzymatic cleaning solution per the manufacturer¿s instructions.Soak soiled instrument for 5 minutes.Rinse the instrument thoroughly with warm tap water.Rinse all lumens, internal areas, sliding mechanisms, and hinged joints, actuating sliding mechanisms and hinged joints while rinsing.Ultrasonically clean instrument for 10 minutes in neutral ph detergent, prepared in accordance with the manufacturer¿s instructions.Rinse the instrument thoroughly with warm tap water.Rinse all lumens, internal areas, sliding mechanisms, and hinged joints.Actuate sliding mechanisms and hinged joints while rinsing.Dry immediately after final rinse.Dry internal areas with filtered compressed air, if available".For sterilization instructions, ifu-0902-00-721 rev.K states that a pre-vacuum cycle type needs to be followed with a minimum temperature and a minimum exposure time depending if the region is in the united states (us) or outside the united states (ous): for us, a 270°f (132°c) and 4 minutes / 30 minute dry time for metal or metal/poly trays, and for ous, 273°f (134°c) and 3 minutes / 30 minute dry time for metal or metal/poly trays.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the quickset depth gauge 70mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code ag1007 provided is not a valid finished goods lot number.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "this instrument is composed of 1 part.The depth gauge has been bent as per the images attached." the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the tip of quickset depth gauge 70mm was bent.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the quickset depth gauge 70mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code ag1007 provided is not a valid finished goods lot#.

• Brand Name: QUICKSET DEPTH GAUGE 70MM
• Type of Device: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18493164
• MDR Text Key: 332667625
• Report Number: 1818910-2024-00855
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10603295109358
• UDI-Public: 10603295109358
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227460000
• Device Lot Number: AG1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1