MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283429

Device Problems Break (1069); Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(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) - incomplete.The expiration date is not currently available.

Event Description

It was reported by our affiliate that metal shedding from ultra aggressive plus blades.No patient consequence.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.

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.Udi: (b)(4) - incomplete.The expiration date is not currently available.

Event Description

Additional information received from affiliate on 10july2018: it was noted the metal shavings occurred during a knee surgery (debrid ablation).The complaint did not result in surgical delay of greater than thirty (30) minutes or an inability to complete the procedure as intended.The fragments were retrieved by suction of shaver; without ablation of new tissue.Alternatives were readily available and the procedure was completed with a similar device.There were no procedural or patient anatomy factors which may have contributed to the breakage.No surgical intervention is planned.It was noted very little particulates/shavings remained in the patient; there was no harm to the patient.

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.The manufacturer contact name has been updated as (b)(6).Contact phone number and email address have been updated accordingly.Additional information: the exp date was reported as unknown in the initial report and has been updated as 10/31/2022; therefore, udi: (b)(4).Investigation summary: the complaint device was received and inspected.The complaint was confirmed.The device was forwarded to supplier quality engineering for further investigation.The supplier quality engineer indicated that when the device was rotated there was no resistance felt and no binding detected.Scratches and gouges in a rotational, horizontal pattern along the length of the inner blade tip and interior of the outer blade tip was observed.The supplier indicated that all machining steps including electropolish, greasing and heat treatment were performed according to specification.Inspection for concentricity, hardness and dimensional analysis that is critical to quality (ctq) showed no signs of anomalies that would contribute to the reported failure.Processing steps and equipment were investigated, and all steps were performed without incident or changes to the equipment including non-standard preventative maintenance (pm).Given the information provided we cannot discern a definitive root cause for the reported failure.A design review has been initiated to further investigate this failure.The device history record (dhr) review indicated that non-conformance conditions were identified, however the issues identified are unrelated to the complaint condition.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.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.

• Brand Name: ULTRA AGGRESSIVE PLUS 4.0MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7526622
• MDR Text Key: 108668181
• Report Number: 1221934-2018-50693
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 283429
• Device Lot Number: M1711046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other