MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREWDRIVER

Model Number	CS 33825-01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A previous mdr has been filed on the same product number tip breaking off.We attempted to investigate whether the tip broke off inside the patient and had to be removed or if it broke outside the patient and did not affect surgery.We have reached out and talked to the distributor but were not able to get a definitive answer on what happened, thus we are reporting as if the tip broke off in the patient.
Event or Problem Description
We received a complaint that the screwdriver had sheared off during the case.When the product was received back we discovered the tip had broken off.

• Brand Name: UCENTUM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 9124031
• Report Number: 9612420-2019-00051
• Device Sequence Number: 2401994
• Product Code: NKB
• UDI-Device Identifier: 04052536081202
• UDI-Public: 4052536081202
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: No Information
• Device Model Number: CS 33825-01
• Device Catalogue Number: CS 3825-01
• Device Lot Number: U003811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/29/2021
• 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: Hospitalization