MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP INSTRUMENT HOLDER 10-1; DEPUY CMW CEMENTING ACCESSORIES : INSERTION DEVICES

Catalog Number 621AI05

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In this type of surgery the technicians do not wash and assist from outside, the instrumenters of the establishment are responsible for performing the technical part.At the time of the placement of the biostop number 12 plug, the healthcare professional assembles the setter together with the nut plug adapter 12 that is screwed on the tip of the cap so that the cap to be implanted can then be placed.The adapter is threaded, the plug does not rock, it is only mounted on the adapter so after being placed by a maneuver the fitting is removed back so that the plug is implanted.In this case, while the technical assistant explained the steps to be followed to the healthcare professional, the doctor places the cap and performs a unscrewing maneuver to remove the cap fitting, which causes the plug and the medullary canal to remain.Adapter of the same.After this fact, this error is detected and the doctor takes care of his bad maneuver, leaving the instruments in the patient's channel, which could not be removed.

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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: product complaint (b)(4).Investigation summary : the complaint states: ¿event: in this type of surgery the technicians do not wash and assist from outside, the instrumenters of the establishment are responsible for performing the technical part.At the time of the placement of the biostop number 12 plug, the healthcare professional assembles the setter together with the nut plug adapter 12 that is screwed on the tip of the cap so that the cap to be implanted can then be placed.The adapter is threaded, the plug does not rock, it is only mounted on the adapter so after being placed by a maneuver the fitting is removed back so that the plug is implanted.In this case, while the technical assistant explained the steps to be followed to the healthcare professional, the doctor places the cap and performs a unscrewing maneuver to remove the cap fitting, which causes the plug and the medullary canal to remain.Adapter of the same.After this fact, this error is detected and the doctor takes care of his bad maneuver, leaving the instruments in the patient's channel, which could not be removed.¿ the introducer rod supplied to customers comes as part of a set along with seven sizing trials which are used to determine the size of the medullary canal and the size of the biostop g bioresorbable cement restrictor to be implanted, and four restrictor holders which are used to fit the biostop g restrictor into the medullary canal.These sizing trials and restrictor holders are detachable and interchangeable, dependent on the size of the medullary canal which is individual to the patient.They can therefore be screwed on and off the end of the introducer rod.The complaint description states that the doctor performed ¿a unscrewing maneuver¿.This rotation in the withdrawal action resulted in the holder being left implanted within the patient.There is a highlighted warning in the ifu for the instrument set (ifu-0563-968) under the special warnings section, which states the following: "do not rotate the unit, which could unscrew the sizing trial or the restrictor holder in the medullary canal.This would make it very difficult to remove it from the canal".This failure mode is also highlighted in the dfmea (dva-107701-fde rev 9) on lines 133-135.The dfmea states: "the four holders have m5 screw threads, with 6mm depth of thread (drawing dwg-606).Potentially, the sizing trials can unscrew from the introducer rod.There have been customer complaints of detachment of accidental detachment of sizing trials and holders from the introducer rod.However, the four holders are machined from passivated 316 lvm stainless steel that is considered biocompatible and suitable for medical instruments and for permanent implants.If implanted, there is a risk that the holder could prevent the hip prosthesis to being positioned correctly.However, as part of the surgical process the surgeon checks that the position of the prosthesis is acceptable.If the prosthesis is positioned too high, due to the holder being underneath, the surgeon would push the prosthesis further until it reaches the appropriate level.The pressure applied by the surgeon on the prosthesis may cause the bone cement restrictor to be displaced lower into the femoral canal.This is not an issue as this device is resorbable and would still allow pressurisation of the bone cement and fixation of the prosthesis in the correct position.The holder may be implanted in a position in contact with the hip prosthesis.However, both implant and holder would be encapsulated in bone cement during the pressurisation process.Surfaces of the hip prosthesis and holder are similar so both item surfaces would interact in a similar way with bone cement.Both items would be locked in place by the bone cement, it is therefore unlikely that contact between the holder and the hip prosthesis would generate metal debris.No adverse tissue reaction has been linked to the implantation of a holder.Considering the information included in the ifu, the low impact on the hip prosthesis fixation, the low risk of metal debris and the biocompatibility of the material used to manufacture the holder, the team agreed that the occurrence level for adverse tissue reaction is remote." instructions for use ifu-0563-968 state: "the instrumentation set should only be used in conjunction with the biostop® g bioresorbable cement restrictor.Screw sizing trials or restrictor holders fully home onto the introducer.Do not twist the rod and do not apply force.Do not rotate the unit, which could unscrew the sizing trial or the restrictor holder in the medullary canal.This would make it very difficult to remove it from the canal." the complaint description confirms that the cause is user error.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.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 required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BIOSTOP INSTRUMENT HOLDER 10-1
• Type of Device: DEPUY CMW CEMENTING ACCESSORIES : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9078967
• MDR Text Key: 186357587
• Report Number: 1818910-2019-105030
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 621AI05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1