MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723650
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, that the patient underwent a primary surgery for degenerative scoliosis of the l2-3-4.The patient was implanted with the expedium verse and six (6) pedicle screws.The rod was placed on the left and fixation was performed using the correction key inserter, three (3) correction keys and hand tightening.The left inner screws were fixated using a derotation maneuver with the rod holder and hand tightening.Next the rod was place on the ride side using hand that fixation with three (3) set screws.The final tightening was performed on the three (3) correction keys and then the inner set screws with the torque limiting handle and counter torque.It was then noticed that the inner set screw on l4 could not be tightened and kept turning.The final tightening of the set screws on the right sided rod was performed and the removal of the correction key on the left l4.This was replaced by a set screw which also could not be tightened.It was discovered that the screwhead was damaged.Finally, all of the set screws and the left rod were removed so the l4 screw could be replaced with a bigger screw.The surgery was completed successfully with a twenty (20) minute surgical delay.Concomitant devices: unknown pedicle screws (part# unknown, lot# unknown, quantity 6).Unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown rod holder (part# unknown, lot# unknown, quantity unknown).Unknown torque limiting handle (part# unknown, lot# unknown, quantity unknown).Unknown counter torque (part# unknown, lot# unknown, quantity unknown).Unknown correction key inserter (part# unknown, lot# unknown, quantity unknown).Unknown tightener (part# unknown, lot# unknown, quantity unknown).Unknown setscrews (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 5.5 exp verse fen scr 6.0x50.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: d9: h3, h4, h6: the dhr of product code: 199723650.Lot : 223365.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 17.11.2018.Qty: 30.Visual inspection: the 5.5 exp verse fen scr 6.0x50 (part #: 199723650, lot #: 223365) was received at us customer quality (cq).Visual inspection of the complaint device showed the screw was stuck in one angle and could not rotate; this condition is expected due to the device being explanted.Stripped internal thread was observed on the component part # 887042533, expedium verse - head.Functional test: a functional assessment was not performed with the complaint device due the post operation condition of the device.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: no dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as a screw head was observed to have a stripped thread.This condition could lead to the reported loose condition after tightening as the thread was damage.However, the stripped thread observed inside the screw head could be due to the "strong hand tightening".Although no root cause could definitively be determined for the reported complaint condition, it is likely the device experienced unintended forces.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12059629
• Report Number: 1526439-2021-01284
• Device Sequence Number: 3348455
• Product Code: PML
• UDI-Device Identifier: 10705034403076
• UDI-Public: 10705034403076
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Model Number: 199723650
• Device Catalogue Number: 199723650
• Device Lot Number: 223365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CORRECTION KEY INSERTER; UNKNOWN COUNTER TORQUE; UNKNOWN LOCKING/SET SCREWS; UNKNOWN ROD HOLDER; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN TIGHTENER; UNKNOWN TORQUE DEVICES; VERSE CORRECTION KEY