MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FLEXIBLE AO BAYONET SHAFT Ø 6.5 L 135; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.26.10.0213

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

The other instrument involved in the case is the flexible bayonet drill ø 3.2 mm shaft l 56 reference 01.26.10.0012, the lot of this instrument in unknown at this time.Preliminary investigation performed on 12 february 2018 by r&d product manager based on the picture received: the cause of the deformation of the instrument flexible shaft may have been influenced by cumulative wear over multiple uses (application and sterilization), application of forces in excess of the bayonet's resistance torque, and/or an excessive curvature/flexion.The manufacturer of the devices was informed on 12 february 2018 about the issue.On 14 february 2018 hpf reported the following investigation to medacta international: document review - flexible ao bayonet shaft reference 01.26.10.0213, lot16h8957: batch released on date: 08/august/2016, n.Of pieces released: (b)(4) all the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.No similar cases reported on this lot.There aren't non conformity elements in the document review.-inspection - (both the items shown in the picture): flexible shaft reference 01.26.10.0213 lot 16h8957: as shown in the picture above, the spring of the flexible bayonet shaft broke on the flextion point.It is possible suppose that the breakage of the device could have been caused by different factors: first of all, the bayonet could broke because of the normal wear (use and sterilization).Furthermore the cause of this breakage could be the excess of the bayonet's resistance torque or an excess of the curve while using the device (corner too tight).Flexible bayonette drill reference 01.26.10.0012 lot not available : the drill bit broke in (b)(4) pieces.It is possible suppose that the rupture could have been caused by a drill flexion during the use which led to the drill breakage.

Event Description

During surgery the flexible ao bayonet shaft bent.Moreover, when extracting the drill bit, it broke in half.No fragments fell into the patient.The surgeon used a secondary bit and flexible ao bayonet shaft to complete the surgery.Five minutes of delay.The surgery was completed successfully.

Event Description

During surgery the flexible ao bayonet shaft bent.Moreover, when extracting the drill bit, it broke in half.No fragments fell into the patient.The surgeon used a secondary bit and flexible ao bayonet shaft to complete the surgery.5 minutes of delay.The surgery was completed successfully.

• Brand Name: FLEXIBLE AO BAYONET SHAFT Ø 6.5 L 135
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7269594
• MDR Text Key: 100021392
• Report Number: 3005180920-2018-00041
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/14/2018,03/29/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.10.0213
• Device Lot Number: 16H8957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/14/2018
• Distributor Facility Aware Date: 01/15/2018
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR