MAUDE Adverse Event Report: ORTHOFIX SRL HANDSET FOR OSCAR II

Model Number OH300

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Hold for tyonie 03/27/2018 analysis of historical records: on july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.Handset, (b)(4), batch 2h2926 (please refer to mfr report 9680825-2018-00025): device manufactured by orthosonics ltd.Reducer bar, (b)(4), batch wo/12749/a (please refer to mfr report 9680825-2018-00026): device manufactured by orthosonics ltd.Piercer probe, (b)(4), batch either b1065948 or b1209271 (please refer to mfr report 9680825-2018-00027): orthofix srl checked the internal records related to the controls made on the batch b1065948 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) probes.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint received from this specific device lot.Orthofix srl checked the internal records related to the controls made on the batch b1209271 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) probes.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint received from this specific device lot.Technical evaluation: on july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The returned devices ((b)(4)), received on february 13th, 2018, were examined by orthofix srl quality engineering department and then sent to the supplier 4easytech for the technical evaluation.Handset, (b)(4), batch 2h2926 (please refer to mfr report 9680825-2018-00025): the cement removal handset for oscar 2 (device code oh300 batch 2h2926) is not functioning properly.The horn is damaged and the screwing hole is locked.The threaded bottom of the long extension reducer bar is broken inside.The switch diaphragm is not centered so the switch does not work properly.It remains pressed or it does not start when pressed.Reducer bar, (b)(4), batch wo/12749/a (please refer to mfr report 9680825-2018-00026): the visual check confirmed the problem notified; the device is broken in correspondence to the end threaded part.The missing part is stuck in the handset code (b)(4).No other anomalies have been found.The dimensional check did not evidence any anomalies.The device was then sent to an external laboratory for the raw material analysis and failure investigation.The results of the technical analysis confirmed the raw material conformity to specification.The device broke due to bending fatigue failure.3) piercer probe, (b)(4), batch either b1065948 or b1209271 (please refer to mfr report 9680825-2018-00027): a technical evaluation of the probe code ohp2080su was not possible as it was discarded by the user.Final comments handset, (b)(4), batch 2h2926 (please refer to mfr report 9680825-2018-00025): the first problem (damaging of the horn) is attributable to the failure of the long extension reducer bar ((b)(4)).The threaded bottom of the reducer bar is broken inside.The second problem, related to the switch, is most likely to be attributable to pressure to which the device was subjected during cleaning and sterilization cycles.This caused a detachment of the electrical component from the silicone switch.This may happen after multiple reprocessing cycles as a result of wear and tear of the silicone switch.2) reducer bar, device code ohre2001su batch wo/12749/a (please refer to mfr report 9680825-2018-00026): the technical analysis concluded that the raw material of the returned device is conforming to specification.The device broke due to fatigue failure.This breakage is attributable to the stresses acting on the probe (ultrasound or manual stresses) during repeated uses.3) piercer probe, (b)(4), batch either b1065948 or b1209271 (please refer to mfr report 9680825-2018-00027): a technical evaluation of the probe concerned was not performed as the device was discarded by the user.Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.Orthofix srl historical records shows that no other similar notifications have been received in regards to these specific device lots.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: hospital name: (b)(6) hospital, surgeon's name: mr.(b)(6), date of initial surgery: (b)(6) 2018, body part to which device was applied: hip, surgery description: correction, patient information: n.A, problem observed during: clinical use on patient/intraoperative, type of problem: device functional problem, event description: 1x oscar 2 handset oh300 s/n (b)(4) was used with items below: the 1x long extension bar ohre2001su (s/n (b)(4)) and the 1x ohp2080su (either b1065948 or b1209271 - this cannot be confirmed).Long extension bar sheared where this screws into the handset.8mm piercer probe sheared 3-4 cm below the tip.The tip was retrieved from the patient but both components were discarded.The complaint report form also indicates: the device failure did not have any adverse effects on patient, the initial surgery was not completed with the device, a replacement device was immediately available to complete the surgery, the event did not lead to a clinically relevant increase in the duration of the surgical procedure, an additional surgery was not required, a medical intervention (outpatient clinic) was not required, copies of the operative reports are not available, copies of the x-ray images are not available, no information is available on patient current health condition.Devices involved: handset, device code oh300 batch 2h2926: please kindly refer to mfr report 9680825-2018-00025.The 1 reducer bar, device code ohre2001su batch wo/12749/a: please kindly refer to mfr report 9680825-2018-00026.The 1 piercer probe, device code ohp2080su batch either b1065948 or b1209271: please kindly refer to mfr report 9680825-2018-00027.(b)(4).

• Brand Name: HANDSET FOR OSCAR II
• Type of Device: HANDSET FOR OSCAR II
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7373544
• MDR Text Key: 103597473
• Report Number: 9680825-2018-00025
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OH300
• Device Catalogue Number: OH300
• Device Lot Number: 2H2926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention