MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS SHORT NAIL 125° L180MM D10MM STERILE

Model Number 99-T93025

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 193337 batch g001 before the market release. No anomalies have been found. The original lot, manufactured in 2017 was comprised of(b)(4)devices. (b)(4) of them have already been distributed to the market. Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93025 batch ad1756 before the market release. No anomalies have been found. The original lot, manufactured in 2017 was comprised of (b)(4) devices. All of them have already been distributed to the market. Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93025 batch b1291742 before the market release. No anomalies have been found. The original lot, manufactured in 2019 was comprised of (b)(4)devices. All of them have already been distributed to the market. Technical evaluation: the technical evaluation of the devices involved, received on 17 october 2019 is currently on going. Medical evaluation: the information made available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available. As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. Please kindly refer also to mfr report number 9680825-2019-00072 and 9680825-2019-00074.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6). Surgeon's name: dr. (b)(6). Date of surgery: (b)(6) 2019. Body part to which device was applied: femur proximal. Surgery description: fracture treatment. Patient information: (b)(6), female, (b)(6), 168 cm. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: screw extractor (ref 193337) got blocked in cephalic screw. This extraction of the lag screw was impossible with the extract device. When the device was put in (b)(6), as the lag screw was too short, the surgeon tried to extract it during (b)(6) surgery, with no success. So he probably damaged the lag screw thread during the first surgery. When they tried to extract the screw 3 months after, so last friday (b)(6), then couldn't get the tread. So they tried with the screw extractor (size 4-9mm) with the universal chuck to turn with no success. The screw extractor's thread and the lag screw thread completely cold welding. The complaint report form also indicates: the device failure had adverse effects on patient. The initial surgery was not completed with the device. A replacement device of same model was not immediately available to complete. Surgery: the surgery was completed with a hip protesis. The event led to a clinically relevant increase in the duration of the surgical. Procedure: longest anestesia. Timing of ablation longer than supposed. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative report are not available. Copies of the x-ray images are available (pre-operative images). Information about patient current health condition: ok. Further information received from the local distributor on 10th october 2019: the surgery of 4th was a replacement for protesis. The screw too short gave pain to the patient. Pain in the hip. She could walk properly. So the decide to change it by a protesis. (b)(4).

• Brand Name: CHIMAERA HFS SHORT NAIL 125° L180MM D10MM STERILE
• Type of Device: CHIMAERA HFS SHORT NAIL 125° L180MM D10MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 9259369
• MDR Text Key: 184761903
• Report Number: 9680825-2019-00073
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 99-T93025
• Device Catalogue Number: 99-T93025
• Device Lot Number: AD1756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/31/2019 Patient Sequence Number: 1