MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) RESECTOR AGGRESIVE; SHAVER BLADE

Model Number 89975.0333

Device Problems Break (1069); Device Reprocessing Problem (1091)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Actual device returned to manufacturer on 09/30/2016.Investigation/evaluation currently in process.A request for missing/incomplete information sent to user facility, no response as of 10/19/2016.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).

Event Description

(b)(4) was notified by the physician that the inner blade of the device in question broke.The device broke at the beginning of the procedure to shave the inner meniscus posterior horn.The broken piece could not be removed and the foreign object remains in the knee of the patient.A postoperative diagnostic radiology was performed and the foreign object was located in the patients dorsal joint space.The doctor has informed the patient about the incident.Patient indicated they are having no issues at this time.

Manufacturer Narrative

Follow up #1 the user informed that the application was completed and the patient was discharged.In the postoperative x-ray diagnosis, the remaining fragment, about 5.5mm in length and a diameter of 3.2mm, can be seen in the dorsal joint space.The patient was informed by the user about the incident and an open joint revision may be needed.So far, the patient has no complaints.Lot manufactured 05feb2016 and consists of (b)(4) pieces.Device in question was sold to facility on 09jun2016.Device was examination, by internal and external independent bodies, and revealed the resector breakage, and stress corrosion cracking and very pronounced damage to the protective surface coating.Data is stored on a contactless memory chip and the data records indicate that the resector was placed on the motor handle 35 times and has been in operation for 1 hour 41 minutes and 48 seconds.Damage to device can be attributed to the long use of the resector.From our point of view, the incident is linked to user error due the following circumstances: - mechanical wear paired with an exceptionally long service life.- chemical thermal wear due to op residues from high number of instrument preparations.As there are no indications of a product problem, further measures are not required.Potential hazards identified in risk assessment e5-52 r04 (reusable tools) with the appropriate extent of damage and probability of occurrence are taken into account and assessed with an acceptable risk.This rating is still valid for the current case.Richard wolf (b)(4) considers this matter closed.However, in the event richard wolf (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4).

Event Description

Follow up #1.

• Brand Name: RESECTOR AGGRESIVE
• Type of Device: SHAVER BLADE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6048866
• MDR Text Key: 58603310
• Report Number: 9611102-2016-00009
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: K080617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 89975.0333
• Device Lot Number: 2107201505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other