MAUDE Adverse Event Report: DEPUY SPINE INC EXP5.5 DEROTATION QUICK STICK; MISC ORTHO SURGICAL INSTR

Model Number	279788935
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales representative 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 europe reports an event in (b)(6) as follows: it was reported that a quick stick and derotation rack was sticking between rack and the quick stick.It was not defined which piece is causing it to stick.Another quick stick and de-rotation rack was used to complete the successful procedure.No other details were given.Concomitant product: exp5.5 derotation quick stick, lot #mi71013, qty unknown.Exp 5.5 derotation qck stick f, lot/qty unknown.This complaint involves two (2) devices.This report is for one (1) exp5.5 derotation quick stick.This report is 1 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.H10: additional narrative: h3, h4, h6: a review of the receiving inspection (ri) for exp5.5 derotation quick stick was conducted identifying that lot number mi33612 was released in a single batch on february 09, 2014 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.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.H11: corrected data: b3.B4/g3: alert date initially reported as january 09, 2021 but should have been january 08, 2021.D10.

• Brand Name: EXP5.5 DEROTATION QUICK STICK
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11258644
• Report Number: 1526439-2021-00215
• Device Sequence Number: 2688594
• Product Code: LXH
• UDI-Device Identifier: 10705034203355
• UDI-Public: (01)10705034203355
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 279788935
• Device Catalogue Number: 279788935
• Device Lot Number: MI33612
• Initial Date Received by Manufacturer: 01/09/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP 5.5 DEROTATION QCK STICK F; EXP5.5 DEROTATION QUICK STICK; EXP5.5 DEROTATION QUICK STICK