MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI STD CROSS CONNECTOR 37MM - STERILE

Catalog Number	03.75.715
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 8 august 2019: lot 1822330: (b)(4) items manufactured and released on 5-nov-2018.Expiration date: 2023-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d project manager: based on the event description, it was realized that it was rather difficult to position the cross-connector due to overall implant design as well as the patient anatomy.The information given on the implant is the real rod-to-rod distance.However, during the selection of cross-connector size, it has to be considered the minimal distance between the lips of the clamps when seated in full open position.In order to give the best support to the users for size selection, a market communication will be addressed to additionally detail the proper technique.At the end of the surgery, the user preferred not to implant the cross-connector because of additional bone removal was necessary.So, it is supposed that there were no safety related concern that might negatively affect the patient due to not positioning the cross-connector.The implant is features with a friction interface to prevent loosing and sliding of the clamp from the transversal bar, which makes the clamp more stable over the transversal bar.The overall dimension of the clamp should be well considered in relation to patient anatomy as well as the distance between the adjacent screw-head, in order to allow the cross-connector positioning.During visual inspection it was observed that all the locking screws were fully engaged in the clamps, reducing the clearance necessary to position the clamp over the poly-axial screws-rods construct.In case of excessive engagement, the user has to release the locking screw in order to ease the position.The locking screw can be further disengaged from the clamp with the temporary set-screwdriver included in the instrument set.Visual inspection and functional checking confirmed that the implant complies with the technical specification and it was functional for the intended use.Additional implant involved in the event, batch review performed on 8 august 2019 must mini 03.75.716 must mini std cross connector 44mm - sterile (k171369) lot.1822331.Lot 1822331: (b)(4) items manufactured and released on 5-nov-2018.Expiration date: 2023-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Std cross connector length 37mm: although the measured value of rod distance was 37mm, it was not able to set.Std cross connector length 44mm: although there was no problem for the size of std cross connector length 44mm, the connection part with rod did not move smoothly.Moreover the connection part with rod was thick, so in order to use it the surgeon needed to remove the bone additionally.Therefore the surgeon was not able to use it for the surgery.The surgeon finished the surgery without using the std cross connector.Due to this event the surgery was prolonged about 20 minutes.It was hard to use it because the connection part with rod did not move smoothly and it was thick.It did not make sense to use it in case additionally bone remove is required.

• Brand Name: MUST MINI STD CROSS CONNECTOR 37MM - STERILE
• Common Device Name: CROSS CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8959261
• Report Number: 3005180920-2019-00727
• Device Sequence Number: 2417264
• Product Code: NKG
• UDI-Device Identifier: 07630040706674
• UDI-Public: 07630040706674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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 Expiration Date: 10/22/2023
• Device Catalogue Number: 03.75.715
• Device Lot Number: 1822330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: Other