MAUDE Adverse Event Report: RICHARD WOLF GMBH ARTHROLINE PUNCH W 4,6MM H 1,6MM; ARTHROSCOPIC PUNCH

Model Number	89140.0102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to richard wolf (b)(4) for evaluation.The material hardness was found to be within specification and the production records show no anomalies.The result of the investigation is that the type of break is consistent with too much force being applied to the instrument (the break was caused by overloading).In the ifu, the user is informed about the correct use of the instrument.The application of too much force can lead to breakage or damage to the product that can compromise the functionality.The user is also instructed to carry out a visual and function inspection of the device before and after each use, and that no missing or broken parts are left in the patient.A review of the complaints database showed that between 01/01/2015 and 05/21/2019, 226 punches (part # 89140.0102) were sold and there were a total of (b)(4) complaints.There was one other case where the moving jaw part had broken off and in that case, the damage was also evaluated to be a result of overloading/applying too much force.Possible hazards are addressed in the risk assessment b1-2 r04 with the respective severity and probability of occurrence rated as acceptable, and continue to be valid in the context of this complaint.The problem investigated in this case does not describe a general product problem that points to a non-conformity, negative trend or any new health hazard.As the reported issue represents a handling error by the user, a systemic issue is not apparent and the warnings and cautions contained in the ifu ga-b 209 related to the problem are considered to be sufficient, no further action is warranted except for the continued surveillance of product complaints so that any negative trends can be established.
Event or Problem Description
According to the customer, on (b)(6) 2019, the jaw part of the punch was broken off during surgery and remained in the joint.The surgeon was able to get the jaw part out of the knee joint with the help of a grasper.A questionnaire was sent to the customer.The customer confirmed that the problem occurred during use; when the punch was opened, a part of the jaw fell into the knee.The broken part was removed without any problems or delay and there was no patient harm.The procedure was completed successfully with no consequences for the patient.

• Brand Name: ARTHROLINE PUNCH W 4,6MM H 1,6MM
• Common Device Name: ARTHROSCOPIC PUNCH
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10054641
• Report Number: 9611102-2019-00007
• Device Sequence Number: 19567471
• Product Code: NBH
• UDI-Device Identifier: 04055207046241
• UDI-Public: 04055207046241
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K953868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 89140.0102
• Device Catalogue Number: 89140.0102
• Device Lot Number: 4500130933
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention