MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP DISPOSABLES SYSTM; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Catalog Number 232037

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.(b)(4).

Event Description

It was reported by the sales rep via phone that during an acl procedure when using the beath pin in the customer's rigidloop disposable system metal shavings were created.The surgeon stopped using the pin and removed the metal shavings with the suction from the shaver.The surgeon opened another rigidloop disposable system started to use the beath pin and halfway into using the pin it was noticed that metal shaving were created.This is when they realized that the customer's anteromedial femoral aimer 6.5mm that was being used with the pins has a spur on it causing the pins to create metal shavings.The surgeon removed the metal shavings again with the suction from the shaver.The procedure was completed with another aimer and the second disposable system.There was no patient harm but there was a five minute surgical delay to the case.The sales rep confirmed that there was no debris left in the patient.The sales rep could not provide a lot number for the aimer.The disposable systems were discarded by the customer but the aimer will be returning for evaluation.

Manufacturer Narrative

Product complaint # (b)(4).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.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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on 09/26/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: RIGIDLOOP DISPOSABLES SYSTM
• Type of Device: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9169087
• MDR Text Key: 208372838
• Report Number: 1221934-2019-58868
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 10886705022830
• UDI-Public: 10886705022830
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 232037
• Device Lot Number: 4L35088
• Date Manufacturer Received: 10/24/2019
• Patient Sequence Number: 1