MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number 2307-92-003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: visual examination of the returned device found 1 of the 4 tabs broken off.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Visual examination of the returned locking screwdriver body found one of the four tabs broken off.The broken off tab was not returned.Previous investigations identified a trend for the teeth breaking.A health hazard evaluation meeting was conducted on (b)(6) 2013 and identified a potential harm, as documented in (b)(4) via eco (b)(4), which was completed on (b)(6) 2013.The issue and harm were forwarded to the quality review board via (b)(4) on (b)(6) 2013, and it was determined that a field action was not necessary due to the low occurrence rate.Mdd (b)(4) was initiated on (b)(6) 2013 to determine root cause and corrective actions needed.A sales mail was issued to the us sales force on 10/01/2013 titled "locking screwdriver technique reminder" to reinforce the proper use of the driver (e.G.Keeping the driver in axial alignment with the screw and using the driver sleeve).These items are already contained in the surgical technique.Capa (b)(4) was closed on may 9, 2016, identifying the root cause to be inadequate design.The actions implemented as a result of this capa have addressed the root cause of inadequate design.The redesign of the delta extend screwdriver guide ensure that the screws are captured properly and torqued "on-axis," thus preventing overloading of the teeth in the screwdriver, which could result in the fracturing of the teeth as seen in the initial complaints.The material change from (b)(4) stainless to (b)(4) stainless resulted in a more resilient device and one in which the failure mode changed from fracture (of the teeth) to deformation.Co (b)(4) was released on december 11, 2015 to change the material from 455 stainless to 465 stainless resulted in a more resilient device and one in which the failure mode changed from fracture (of the teeth) to deformation.The changes addressed in co (b)(4) were carried over to co (b)(4) and release on january 28, 2020.The initial pve allowing for the receipt of the initial round of drivers is recorded in (b)(4).The first batches (5357743 and 5357744) of drivers per the new design were manufactured on february 7, 2020.The current complaint sample device was manufactured prior to the implementation of the new design.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.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.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 as "we have the following complaints closed and the respective follow ups were made for the mismatch products.If that is the case, the information for each device and complaint is the following: (b)(4) mismatch device: 230792003 locking screwdriver body lot# 5002530 and (b)(4).Mismatch device: 254401014 attune spacer block lot# bfa0vpv" (b)(6) 2022 visual examination of the returned locking screwdriver body found one of the four tabs broken off.The broken off tab was not returned.

• Brand Name: LOCKING SCREWDRIVER BODY
• Type of Device: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• 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: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 14017339
• MDR Text Key: 288691889
• Report Number: 1818910-2022-06217
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116561
• UDI-Public: 10603295116561
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-92-003
• Device Catalogue Number: 230792003
• Device Lot Number: 5002530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1