MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704310
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the surgeon had difficulty removing the broken off long-headed tube from the tip.It could only be removed from the tip by using great force.No surgical delay reported.The surgery was completed successfully.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown); unknown screw (part# unknown, lot# unknown, quantity unknown ); unknown set screw (part# unknown, lot# unknown , quantity unknown ).This report is for one (1) expedium spine system tab breaker, body.This is report 1 of 1 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.H3, h6: investigation summary: investigation flow: device interaction/functional.Visual inspection: the expedium tab breaker, body (part # 299704310 / lot # pu148421) was received at us cq.Upon visual inspection, no defects were observed on the device.Functional test: functional test cannot be performed as the mating device was not returned.Complaint replication, unable to perform.Dimensional inspection: dimensional inspection was not performed as internal components were not accessible.Conclusion: the overall complaint was not confirmed for the received expedium tab breaker.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 expedium tab breaker, body was conducted identifying that lot number pu148421 was released in a single batch.Batch1: lot qty of (b)(4) units were released on jun 03, 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.

• Brand Name: EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY
• 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: 10339128
• Report Number: 1526439-2020-01417
• Device Sequence Number: 3748938
• Product Code: LXH
• UDI-Device Identifier: 10705034467375
• UDI-Public: (01)10705034467375
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 299704310
• Device Catalogue Number: 299704310
• Device Lot Number: PU148421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.; UNKNOWN SCREWS.; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS