MAUDE Adverse Event Report: DEPUY MITEK LLC US 7.0 X 75MM REUSABLE OBTURATOR -NS; SURGICAL DRILL GUIDE OBTURATOR

Model Number	214113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mitek employee.Patient code no code available used to capture the patient¿s shoulder arthroscopy surgery.Investigation summary: the complaint device was received and inspected.It was observed that the handle and the shaft of the device had been separated.This complaint can be confirmed.The device is reusable.A visual inspection revealed that the device had been heavily used as distal tip of the shaft has several nicks and a burr on the side.The obturator insert has several nicks and chips in the hardcoat finish.The broken press fit failure could be due to the device being dropped/ mishandled on hard surface causing the press fit to fail.The lot number indicates that the device is about seven years old.Other than the possibility of mishandling, we cannot discern a root cause for this failure mode.At this point in time, no corrective action is required and no further action is warranted.Device history lot.This device was manufactured at advanced biomaterials prior to its removal as an approved supplier for depuy mitek sports medicine; therefore, dhr review cannot be performed for this particular lot number.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.
Event or Problem Description
It was reported by the sales rep via cst that prior to a shoulder repair procedure the 7x75mm reusable obturator (lot: 1111001) was broken.The device is broken at the shaft, it no longer can attach to the handle.The sales rep stated the device was not used on the patient.Item was used to insert a cannula and it broke during a past shoulder arthroscopy case, no patient was harmed.The case was completed with another like-device with no patient harm.There was 5-minute delay, had to find another obturator.The device is being returned for evaluation.This is report 1 for 1 (b)(4).

• Brand Name: 7.0 X 75MM REUSABLE OBTURATOR -NS
• Common Device Name: SURGICAL DRILL GUIDE OBTURATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9124583
• Report Number: 1221934-2019-58577
• Device Sequence Number: 2527991
• Product Code: LXH
• UDI-Device Identifier: 10886705003549
• UDI-Public: (01)10886705003549
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214113
• Device Catalogue Number: 214113
• Device Lot Number: 1111001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1