MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5 CM HEAVY DUTY SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC

Model Number SHORT-HD-G1

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

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.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.During evaluation, the device loctite joints were inspected, and it was determined that there was no loctite residue found on threads of components.The assignable root cause was determined to be due to improper assembly, which is a manufacturing issue, and has been covered under a capa.A review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Udi: (b)(4).

Event Description

It was reported that during pretesting, it was observed that the attachment device was missing components.During in-house engineering evaluation, it was determined that the device could not secure lock cutter device due to the device being disassembled and missing parts.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 5 CM HEAVY DUTY SHORT ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 11798743
• MDR Text Key: 258068199
• Report Number: 1045834-2021-00789
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384016304
• UDI-Public: 00845384016304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHORT-HD-G1
• Device Catalogue Number: SHORT-HD-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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