MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE CAM TGHTNR TORQ HNDL; MISC ORTHO SURGICAL INSTR

Model Number	289707000
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date, during routine incoming inspection of a loaner set, it was observed that the torque handle was found to be out of drawing specification.The drawing specification is.63-.98.The torque tested low ¿ 0.483.The product has been quarantined and is available and is being returned.There was no patient involvement.This complaint involves one (1) device.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.Investigation flow: device interaction/functional.Visual inspection: the uniplate cam tghtnr torq hndl (p/n: 289707000, lot #: km873406) was returned and received at us cq.Upon visual inspection, no issues were observed with the returned components of the device.Functional test: the functional test was performed at fsl owens & minor houston, tx site.During a routine incoming inspection of a loaner set, it was observed that 299707000, torque handle, lot number km873406 was found to be out of drawing specification.The drawing specification is.63-.98 nm.The torque tested low ¿ 0.483 nm.Can the complaint be replicated with the returned devices? yes.Dimensional analysis: no dimensional inspection can be performed as the device failed in the torque test.Document/specification review: based on the date of manufacture all relevant drawings are reflecting the current and manufactured revision were reviewed.Depuy spine loaner set product-specific inspection and verification instructions.Complaint confirmed? yes, the device received failed in the torque test.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the complaint device.There is no indication that a design or manufacturing issue has caused the issue 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 history lot: a review of the receiving inspection (ri) for uniplate cam tghtnr torq hndl was conducted identifying that lot number km873406 was released in a single batch.Batch1: lot qty of 72 units were released on dec 13, 2018 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: UNIPLATE CAM TGHTNR TORQ HNDL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10014598
• Report Number: 1526439-2020-00926
• Device Sequence Number: 2437020
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 289707000
• Device Catalogue Number: 289707000
• Device Lot Number: KM873406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNIPLATE CAM TGHTNR TORQ HNDL