MAUDE Adverse Event Report: ORTHOFIX SRL JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM STERILE

Catalog Number	99-5404532
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of historical records orthofix checked the internal records related to the controls made on the device code 99-5415032 lot b1670879 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of (b)(4) devices.40 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00006).Orthofix checked the internal records related to the controls made on the device code 99-5415065 lot b1771062 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 30 devices.21 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00007 and 9680825-2024-00008).Orthofix checked the internal records related to the controls made on the device code 99-5415070 lot b4301328 before the market release.No anomalies have been found.The original lot, manufactured in 2023, was comprised of (b)(4) devices.8 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00009).Orthofix checked the internal records related to the controls made on the device code 99-5404532 lot b1771063 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of (b)(4) devices.18 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00010).Technical evaluation the technical evaluation on the returned devices is currently on going.As soon as further information and/or the results of the investigation are available, orthofix srl will provide you with a follow up report.Orthofix continues monitoring the devices on the market.
Event or Problem Description
The information initially provided by the local distributor indicates: - product codes: 99-5415032 and 99-5415065 and 99-5415065 and 99-5415070 and 99-5404532 (mfr reports 9680825-2024-00006 and 9680825-2024-00007 and 9680825-2024-00008 and 9680825-2024-00009 and 9680825-2024-00010 respectively) - batch numbers: b1670879 and b1771062 and b1771062 and b4301328 and b1771063 - hospital name: (b)(6) hospital - surgeon's name: dr (b)(6) - date of initial surgery: (b)(6) 2024 - body part to which device was applied: right femoral neck - surgery description: correction - problem observed during: clinical use on patient/intraoperative - type of problem: device functional problem and clinical (patient) problem - event description: the screws are difficult to advance into the bone the complaint report form also indicated: - the device failure did not have any adverse effects on patient - the initial surgery was not completed with the device: operation completed with a competitors device - the event led to a delay in the duration of the surgical procedure: 2 hours - an additional surgery was not required - a medical intervention (outpatient clinic) was not required - copy of operative reports and copy of x-ray images are not available - product is available for return - product was at its first use - patient's current health condition: not available orthofix ref: (b)(4) distributor ref: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records: orthofix checked the internal records related to the controls made on the device code 99-5415032 lot b1670879 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 62 devices.40 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00006).Orthofix checked the internal records related to the controls made on the device code 99-5415065 lot b1771062 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 30 devices.21 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00007 and 9680825-2024-00008).Orthofix checked the internal records related to the controls made on the device code 99-5415070 lot b4301328 before the market release.No anomalies have been found.The original lot, manufactured in 2023, was comprised of 20 devices.8 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00009).Orthofix checked the internal records related to the controls made on the device code 99-5404532 lot b1771063 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 25 devices.18 of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device code.(mfr report 9680825-2024-00010).Technical evaluation: the returned devices, received on february 1, 2024, were examined by orthofix quality operations department.All screws were subjected to visual and functional check as per orthofix specification.In the visual check no issues were detected, except for signs of use, as scratches, residues, wear of threads.The dimensional check did not evidence any anomalies.Conclusions: in the visual check of the returned devices no issues were detected, except for signs of use, as scratches, residues, wear of threads.The dimensional check did not evidence any anomalies.The evidence collected suggest that the returned devices were originally conforming to orthofix specifications.No product problem was evidenced.Orthofix continues monitoring the devices on the market.
Event or Problem Description
The information initially provided by the local distributor indicates: product codes: 99-5415032 and 99-5415065 and 99-5415065 and 99-5415070 and 99-5404532 (mfr reports 9680825-2024-00006 and 9680825-2024-00007 and 9680825-2024-00008 and 9680825-2024-00009 and 9680825-2024-00010 respectively).Batch numbers: b1670879 and b1771062 and b1771062 and b4301328 and b1771063.Hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of initial surgery: (b)(6) 2024.Body part to which device was applied: right femoral neck.Surgery description: correction.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem and clinical (patient) problem.Event description: the screws are difficult to advance into the bone.The complaint report form also indicated: the device failure did not have any adverse effects on patient.The initial surgery was not completed with the device: operation completed with a competitors device.The event led to a delay in the duration of the surgical procedure: 2 hours.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copy of operative reports and copy of x-ray images are not available.Product is available for return.Product was at its first use.Patient's current health condition: not available.Orthofix ref: (b)(4).Distributor ref: jps_wch_0124.

• Brand Name: JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM STERILE
• Common Device Name: JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM 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: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 18693548
• Report Number: 9680825-2024-00010
• Device Sequence Number: 7134608
• Product Code: HRS
• UDI-Device Identifier: 18053800897188
• UDI-Public: 18053800897188
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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 Catalogue Number: 99-5404532
• Device Lot Number: B1771063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown