MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 10 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179722150

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a tlif (transforaminal lumbar interbody fusion) at s1 treating spondylolisthesis, the screwdriver tip broke off during screw insertion.Fragment(s) became stuck with the screws shaft.The surgeon removed the screw and completed the procedure with replacements.There was a, less than, 30-minute surgical delay.All the fragments were removed with the screw.No further information is available.This report is for one (1) expedium spine system polyaxial screw 5.5 x 10 x 50mm this is report 2 of 2 for (b)(4).

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.H10 additional narrative: h3, h6: a product investigation was conducted: investigation flow: device interaction/functional visual inspection: the exp di poly screw 10x50mm ti (part # 179722150, lot # rl274928) was received at us cq.The broken tip of xpdm quick-con di poly screwdriver (part # 279722400, lot # mi63498) was received in stuck condition with in exp di poly screw 10x50mm ti (part # 179722150, lot # rl274928).No other defects were identified.The complaint is confirmed.Functional testing: the screwdriver's broken tip was received in stuck condition in screw.It was not able to be disassembled from the screw.Can the complaint be replicated with the returned device? yes; screwdriver's broken tip was stuck in screw and could not be removed.Dimensional inspection: since distal tip of screwdriver was found to be stuck in the screw, the feature is not accessible for dimension measurement.Document/specification review: no product design issues or manufacturing discrepancies were observed.Conclusion: the overall complaint was confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, the received condition is possible with exceeding lateral forces potentially from off-axis use.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for di polyaxial screw, ti was conducted identifying that lot number rl274928 was released in a single batch.Batch1: lot qty of (b)(4) units were released on feb 15, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

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.H10 additional narrative: updated data-h4 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: EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 10 X 50MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10599455
• MDR Text Key: 208948343
• Report Number: 1526439-2020-01822
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034070162
• UDI-Public: (01)10705034070162
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 179722150
• Device Catalogue Number: 179722150
• Device Lot Number: RL274928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 11/04/2020
• Supplement Dates FDA Received: 10/23/2020; 11/04/2020
• Patient Sequence Number: 1
• Treatment: XPDM QUICK-CON DI POLY SCWDRVR; XPDM QUICK-CON DI POLY SCWDRVR