MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW REAMER, SHORT; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

Additional device information: unique identifier (udi) # (b)(4).The manufacturer did not receive x-rays, or other source documents for review.The device was received, the investigation is pending.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during intramedullary nail implantation the lag screw reamer was fractured and some pieces remained in the patient.Another reamer was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: instrument fracture event description: it was reported that the tip of the znn cmn lag screw reamer (ref:(b)(4).Lot:4501592310) was fractured at the superior medial point of the lag screw/nail interface during reaming in the surgery of left intramedullary medullary nail implantation.Several fragments of the broken reamer were unable to be retrieved and remain in patient.Surgery was completed by another reamer with 15 minutes delay.Review of received data: the per states that, in previous case, surgeon momentarily reamed at wrong angle.Device analysis: visual examination: the reamer has been returned for investigation, but no other retrieved fragments were returned.The tip of reamer were fractured off.Several scratches and loss of coating could be seen on the cutting area.A damaged cutting edge near the fracture site was found.Corrosion spots were identified on the fracture surface; however, the surface does not suggest a fatigue fracture.The corrosion could happen after the fracture.On the inner surface, a spot without coating can be seen, the coating could be scratched off by contacting the 3.2mm pin or other fractured fragments.Based on this visual examination the reported event can be confirmed.Review of product documentation: - compatibility: compatibility check could not be performed as only one product had been reported.Inspection plan: characteristic no.7 feature dimension (10.16 +0.03/-0.03) with scope of testing: aql 1.0.Means of inspection: measuring microscope.Characteristic no.8 feature dimension (6.706 +0.05/-0.05) with scope of testing: aql 1.0.Means of inspection: measuring microscope.Characteristic no.19 feature aau q.26.256 vergueten/ harden and temper / 1.4112 with scope of testing: 100%.Means of inspection: visual.Characteristic no.22 feature material 1.4112/aau q.26.505 with scope of testing: 100%.Means of inspection: visual.Characteristic no.39 feature dimension (3.5 +0.05/-0.05) with scope of testing: aql 1.0.Means of inspection: test pin.Surgical technique: attach the lag screw reamer to the drill.Ream over the 3.2 mm pin to the level of the subchondral bone.While drilling, use the c-arm intermittently to verify position of the reamer and to make sure that the pin is not migrating through the femoral head.Root cause analysis: root cause determination using sap rmw: instrument, breaks, deforms, diverge, or parts remain in wound due to inadequate design for intended performance not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Instrument, breaks, deforms, diverge, or parts remain in wound due to mechanical properties of material insufficient not possible, as according to material compatibility specification sap 214882 the material has been tested.Further, a systematic issue with material would have been detected as part of the issue evaluation assessment.Unrecognized damaged instrument is used due to damaged instrument due to transport not possible, as it is a consignment set.Fracture of instrument due to general corrosion (crevice, pitting, galvanic) possible, as corrosion spots have been found on the fracture surface; however, the corrosion could happen after the fracture.Instrument, breaks, deforms, diverge, or parts remain in wound due to inadequate design for intended performance not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Intraoperative complications due to design specification not met not possible, as a systematic issue with manufacturing would have been detected as part of the issue evaluation assessment.In addition, the raw material certificate and dhr shows the device met all requirements to perform as intended.Damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling possible, as it was reported in the per that the device had been momentarily reaming at wrong angle in previous case.The device might had been damaged already.Damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling possible, as it was reported in the per that the device had been momentarily reaming at wrong angle in previous case.The device might had been damaged already.Instrument breaks or deforms due to off-label abnormal-use possible, as damage, scratch and loss of coating was observed on the device.Moreover, it was reported in the per that the device had been momentarily reaming at wrong angle in previous case.Conclusion: it was reported that the reamer fractured at superior medial point of lag screw/nail interface during the reaming.The fracture could be confirmed by visual examination.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.In the case of migrated pin or mistargeted reamer, the tip could be in contact with thepin or znn nail which leads to high applied force on reamer that cause the fracture.Further, the per states that the device had been momentarily reamed at wrong angle in previous case.It is also possible that the device was already damaged by collided to other hardware.However, a exact root cause could not be determined.The instruments are categorized as external communicating devices with tissue/bone contact for less than 24 hours.Therefore it is recommended to monitor the patient.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2018-01076.

• Brand Name: ZNN, CMN LAG SCREW REAMER, SHORT
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7965205
• MDR Text Key: 123699555
• Report Number: 0009613350-2018-01076
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-2490-003-64
• Device Lot Number: 4501592310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other