MAUDE Adverse Event Report: DEPUY SPINE INC IS BONE MARKER #1; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2050285
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: flow: damage.Visual inspection: visual inspection performed at customer quality (cq) it is observed the marker has some minor scratches/nicks, and is bent on the shorter side of the marker.No other issues were identified.A device failure was identified.Dimensional inspection: drawing: ø of shaft: ø of center cylinder: overall length: measured dimensions: ø shorter end: conforming, ø longer end: conforming, ø center: conforming, l: conforming.Device used: (b)(4).Document/specification review the following drawing(s) was reviewed: bone marker #1: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 is ped marker/ins incl 8 mks was conducted identifying that lot number mi37308 was released in a single batch.Batch1: lot was released on sept 9, 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.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a tlif (transforaminal lumbar interbody fusion) in l4-5 treating spinal stenosis on (b)(6) 2020.The x-ray markers were distorted during insertion into the pedicle.The procedure was completed without surgical delay.No further information is available.This report is for one (1) is bone marker #1.This is report 2 of 4 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.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: IS BONE MARKER #1
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10581804
• Report Number: 1526439-2020-01785
• Device Sequence Number: 1166066
• Product Code: LXH
• UDI-Device Identifier: 10705034004846
• UDI-Public: (01)10705034004846
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 2050285
• Device Catalogue Number: 2050285
• Device Lot Number: MI37308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: IS BONE MARKER #2; IS BONE MARKER #2; IS PED MARKER/INS INCL 8 MKS; IS PED MARKER/INS INCL 8 MKS; IS BONE MARKER #2; IS BONE MARKER #2; IS PED MARKER/INS INCL 8 MKS; IS PED MARKER/INS INCL 8 MKS