MAUDE Adverse Event Report: DEPUY MITEK LLC US 4 MM BARREL BUR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	283469
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional 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.Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
It was reported that during ankle surgery (arthroscopy), metal abrasion was detected.The patient consequence is that there's still some burr in the patient.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch.A follow-up medwatch will be filed as appropriate.(b)(4).The lot number is not currently available.The expiration date is not currently available.
Event or Problem Description
It was reported that during ankle surgery (arthroscopy), metal abrasion was detected.The patient consequence is that there's still some burr in the patient.Additional event information received on 08/31/2018 stated that the failure did not result in any surgical delay or inability to complete the procedure.The procedure was completed by shaving away the metal parts using another shaverblade.There were no procedural or patient anatomy factors that contributed to the breakage.The surgical intervention was not planned.Additional event information received on 10/5/2018 stated that the event occurred intra-op.Additional event information received on 10/8/2018 that these complaint is not coming back.It was discharged from the hospital.
Additional 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.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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).Depuy synthes has been informed that the lot number is not available.

• Brand Name: 4 MM BARREL BUR PLUS
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7834873
• Report Number: 1221934-2018-54564
• Device Sequence Number: 1941091
• Product Code: HRX
• UDI-Device Identifier: 10886705022045
• UDI-Public: 10886705022045
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 283469
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 10/29/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/19/2018; 10/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other