MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET DRILL GUIDE II 3.8MM; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	227454500
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4.Gtin: product was marked for gudid exclusion.Unique identifier (udi) : udi/gtin information is not applicable.Product is no longer marketed.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pinnacle flexible drill bit and drill guide became entangled during use.They kinked up and become ineffective and unusable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : pinnacle flexible drill bit and drill guide became entangled during use.They kinked up and become ineffective and unusable.The scrub nurse gave the surgeon an alternative drill bit and he completed the case using that.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the quickset drill guide ii 3.8mm has the edge of the mating connection hole nicked and deformed.However, the reported jammed condition cannot be confirmed since the device was found disassembled from its mating device.The observed condition of the device could be attributed to a combination of heavy use and unintended use error due to the insertion of the mating device in an off-axis position, friction can occur that damages the connection of the drill guide.The overall complaint was confirmed as the observed condition of the quickset drill guide ii 3.8mm would contribute to the complained device issue.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device was not returned to depuy synthes for evaluation, however photo(s) were provided for review.Review of the provided photo(s) confirms that device is bent and as per visuals it is assumed that device is jammed/seized.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however photo(s) were provided for review.Review of the provided photo(s) confirms that device is bent and as per visuals it is assumed that device is jammed/seized.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Additional 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.

• Brand Name: QUICKSET DRILL GUIDE II 3.8MM
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17287096
• Report Number: 1818910-2023-13773
• Device Sequence Number: 20424579
• Product Code: HTW
• UDI-Device Identifier: 10603295109297
• UDI-Public: 10603295109297
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 227454500
• Device Lot Number: SO2045702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 08/15/2023; 08/23/2023; 08/25/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/25/2023; 08/22/2023; 08/24/2023; 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female