MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704215
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date during the cleaning process it was noticed that the quick stick sleeve did not fit properly on the top notch of the screw head anymore.The tip of inserter appears to be stripped.There was no surgical or patient impact.This report is for one (1) expedium verse spine system quick stick, sleeve.This is report 5 of 10 for (b)(4).This report is linked to (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.H10 additional narrative: h6- there are a total of 24 verse quick stick, sleeves, and 20 verse quick stick, tubes were received at cq.Upon visual inspection, there were locking facilitator springs noticed bent/deformed on the received devices.These all are captured under (b)(4).The complaint can be confirmed for unable to assemble as the bent condition could have caused the reported issue.But there was no stripped condition noticed on the device so the complaint would not be confirmed for the stripped issue.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 preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for verse quick stick, sleeve was conducted identifying that lot number gm5006201 was released in a single batch.Batch1: lot qty of units were released on 27 dec 2017 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.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11118881
• Report Number: 1526439-2021-00054
• Device Sequence Number: 4314572
• Product Code: LXH
• UDI-Device Identifier: 10705034467566
• UDI-Public: (01)10705034467566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 299704215
• Device Catalogue Number: 299704215
• Device Lot Number: GM5006201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1