MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH T-HANDLE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	PET30101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the instrument broke at the welding seam intraoperatively.No fragments were generated.The surgery was completed successfully without any delay and with another available instrument.No adverse patient harm.This report is for one (1) t-handle inserter.This is report 1 of 1 for complaint (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.H3, h6: a product investigation was conducted.Visual inspection: the t-handle inserter (p/n: pet30101, lot #: e19di1385) was received at us cq.Upon visual inspection of the complaint device it was observed that the pet30101 b plif inserter pin was broken at the laser weld next to the thread.No other issues were observed with the returned device.Dimensional inspection: measured dimensions: shaft diameter = conform.Document/specification review.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Investigation conclusion.The complaint condition was confirmed for the t-handle inserter (p/n: pet30101, lot #: e19di1385).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H3, h4, h6: a device history record (dhr) review was conducted: part # pet30101.Synthes lot # e19di1385.Supplier lot # e19di1385 release to warehouse date: 11 may 2020 supplier: (b)(4).No ncr's were generated during production.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: T-HANDLE INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• MDR Report Key: 12313004
• Report Number: 3013730328-2021-00033
• Device Sequence Number: 19834162
• Product Code: MAX
• UDI-Device Identifier: 04260397088388
• UDI-Public: (01)04260397088388
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172888
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: PET30101
• Device Catalogue Number: PET30101
• Device Lot Number: E19DI1385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1