MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TORQUE WRENCH HANDLE 10NM; ENNOVATE INSTRUMENTS

Model Number	SZ228R
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with sz228r - ennovate torque wrench handle 10nm.According to the complaint description, the central processing department (cpd) staff was processing the tray to be ready for surgery and upon inspection, metal shavings fell out of the instrument.Instrument has been pulled and swapped out of the set with the replacements.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
The complaint was re-assessed and this event is no longer considered reportable for the following reason: the review of the risk analysis after investigation revealed that the applicable failure mode is rated with a severity of 2(5).Investigation: visual investigation: the components were examined visually and microscopically.This device was sent to the responsible manufacturing department for investigation.Result: metal chips have been visually detected in the tool holder/blind hole.The gauge function is given.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2(5) xprobability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: due to an employee error, metal chips were left in the hole when the blind hole/tool holder was drilled.By testing with a gauge, the metal chips were pushed further into the blind hole/tool holder.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of he problem is most probably manufacturing - related.Based on the investigation results, a working process was introduced in the work plan, which ensures that the operator/employee checks the hole for metal chips.

• Brand Name: ENNOVATE TORQUE WRENCH HANDLE 10NM
• Common Device Name: ENNOVATE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11568438
• Report Number: 9610612-2021-00263
• Device Sequence Number: 17178446
• Product Code: HXC
• UDI-Device Identifier: 04046964700859
• UDI-Public: 4046964700859
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: SZ228R
• Device Catalogue Number: SZ228R
• Device Lot Number: 52598450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown