MAUDE Adverse Event Report: MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.168.010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the multifunction rod f/insertion instr (p/n: 03.168.010, lot number: 1l72826) was received at us cq.Visual inspection of the complaint device showed that the distal threaded tip of the device was broken, and broken fragment was not returned.Also, the device was observed to have surface scratches.Reported condition of stripped could not be confirmed but the device was found to be broken.No other defect was observed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.However, complaint relevant dimensions cannot be taken because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint was confirmed as the device received in broken condition.While a definitive root cause could not be identified.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part: 03.168.010 lot: 1l72826 manufacturing site: (b)(4).Release to warehouse date: 22 november 2018 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 intraoperatively it was identified that multifunction rod f/insertion instrument is defective (screw thread=demolished).No patient consequence reported.During manufacturer's investigation on (b)(6) 2021 of the returned device, it was identified that the distal threaded tip of the device was broken, and broken fragment was not returned.This report is for one (1) multifunction rod for insertion instruments.This is report 1 of 1 for complaint (b)(4).

• Brand Name: MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• MDR Report Key: 12739052
• Report Number: 8030965-2021-09205
• Device Sequence Number: 17168655
• Product Code: KTT
• UDI-Device Identifier: 07611819657366
• UDI-Public: (01)07611819657366
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: Health Professional
• Device Catalogue Number: 03.168.010
• Device Lot Number: 1L72826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• 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