MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA IM ROD; SURGICAL INSTRUMENT FOR KNEE SURGERIES

Catalog Number	11.00004
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 15 january 2019: lot 188705: (b)(4) items manufactured and released on 18-nov-2018.Expiration date: 2023-10-21.No anomalies found related to the problem.No anomalies found related to the semifinished component mat25149, (b)(4) pieces manufactured and this is the second event on this lot.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d product manager: from picture enclosed, it is possible to notice that the plastic sleeve of the im rod broke and detached from the metal bone.The broken part remained into the patient.The breakage occurred on the tip of the im rod (and then extended to the central part of the im rod but only when the instrument was removed from the bone) the breakage seems to have been caused by a torsional stress.The im rod broke during the attempt to remove it from the canal before performing the distal cut.It is possible that, after having inserted the rod into the canal and fix the distal cutting block on the bone through fixation pins, it was hard to remove the im rod due to some unknown form of restriction (for example presence of another medical device).In the attempt to remove the instruments, the surgeon applied a torsional torque on the rod, that was unexpected constrained, causing its breakage.As result of an internal mechanical test, all lots of the reference object of the complaint could be associated.At this time there is no indication of a lot specific issue or cause.
Event or Problem Description
During the primary knee surgery, and while the surgeon was removing the im rod and positioning the distal femoral cutting guide, the plastic sleeve of the instrument broke.The surgeon had to use an excessive amount of force to remove the im rod and no defects were observed in the im rod prior to insertion.Fragments from the plastic sleeve were left in the patient's inter-medullary canal and the surgeon was unable to recover the fragments.One fragment was 5cm in length.There was a 35 minute delay in the case and the surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director fracture of the plastic sheath of a single-use intra-medullary rod.The femoral canal appears to be extremely small and rather bowed.Probably for these reasons, the im rod got stuck in the canal and was twisted to retrieve it, which originated the fracture.The long-term consequences of the plastic fragments in the canal are not known: the plastic material is approved for surgical instruments, not for long-term implantation.However, the inside of the canal, in absence of stresses, is likely to be a sheltered place and the surgeon decided to leave it there because the alternative would have been an extremely damaging and invasive operation.Visual inspection performed by r&d product manager from visual inspection of the returned part, it is possible to notice that the plastic sleeve of the im rod is cracked all along the metal core.At the tip of the rod, the sleeve detached from the metal core and remained into the patient.The breakage occurred on the tip of the im rod and propagated all along the rod.It was caused by a torsional stress.The im rod broke during the attempt to remove it from the canal before performing the distal cut.After visual inspection, we can confirm what already supposed during preliminary investigation.It is possible that, after having inserted the rod into the canal and fix the distal cutting block on the bone through fixation pins, it was hard to remove the im rod due to some unknown form of restriction.In the attempt to remove the instruments, the surgeon applied a torsional torque on the rod, that was unexpectedly constrained, causing its breakage.As result of an internal mechanical test, all lots of the reference object of the complaint could be associated.At this time there is no indication of a lot specific issue or cause.

• Brand Name: IM ROD
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8260589
• Report Number: 3005180920-2018-01105
• Device Sequence Number: 11313491
• Product Code: LXH
• UDI-Device Identifier: 07630030877377
• UDI-Public: 07630030877377
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/22/2019

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: 10/21/2023
• Device Catalogue Number: 11.00004
• Device Lot Number: 18870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/22/2019
• 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