MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CROSSCONN R2R 35 TO 40MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1020-24-004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp.Reporter is a synthes employee.The device history record (dhr) of product code: (b)(4), lot: rl277411 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on january 13, 2020.Visual inspection: the crossconn r2r 35 to 40 mm was returned, and received at us customer quality (cq).Upon visual inspection, it was observed that the screws of the device were not fully tightened due to which the lower clamp was not fully engaged.There were scratches on the device, but have no impact on the device functionality.No other issues were identified with the returned device.Functional test: a functional test was performed on the returned device.The returned x15 self retaining inserter (part 202000407, lot nn149220, quantity 1) was used to unscrew/tighten the x15 specification screws.During the functional test, the inserter failed to unscrew/tighten the screws as they were jammed.Dimensional inspection: a dimensional inspection was not performed as the screw threads were inaccessible without destruction of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Cross connector r2r - assy.Investigation conclusion: the complaint condition was confirmed for the crossconn r2r 35 to 40 mm.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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
It was reported that during an unknown procedure on (b)(6) 2020, the surgeon could not lock the symphony r2r crosslink.Final locking driving kept stripping screws and tried two cross links, but both stripped out.Fragments were generated, and easily removed.The procedure was successfully completed by switching the final locking driver shaft.There was a surgical delay of twenty (20) minutes.There was no patient consequence.This report is for a crossconn r2r 35 to 40mm.This is report 9 of 9 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.H10 additional narrative: g4: date is updated h3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 102024004 lot: rl277411 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on jan.13, 2020 qty: 75 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: CROSSCONN R2R 35 TO 40MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10671899
• Report Number: 1526439-2020-01937
• Device Sequence Number: 11447521
• Product Code: NKG
• UDI-Device Identifier: 10705034519067
• UDI-Public: (01)10705034519067
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 1020-24-004
• Device Catalogue Number: 102024004
• Device Lot Number: RL277411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AO HANDLE TORQ LIMITING 3.0NM; COUNTER TORQUE R2R X-CONN; CROSSCONN R2R 35 TO 40MM; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN TORQUE DEVICES; X15 DRIVER FINAL TIGHTENER; X15 DRIVER FINAL TIGHTENER; X15 SELF RETAINING INSERTER; X15 SELF RETAINING INSERTER
• Patient Age: 67 YR