MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH SHAVER H 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number PFT10900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 09/06/2022

Event Type  Death  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2022, during an l4-l5 spondylolisthesis procedure, the surgeon injured the aorta during insertion and during use of the 9 mm shaver in the disc space.Emergency laparotomy by vascular surgery was performed to manage the bleeding.The patient died about 45 minutes later due to blood loss.This report involves one shaver, h 9 mm.This is report 1 of 1 for (b)(4).

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.Part#: pft10900, lot#: e17di03981, supplier: (b)(4), batch: lot unit were released on 16 dec 2019 with no discrepancies.No ncrs were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the shaver h 9mm, p/n: pft10900.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the shaver h 9mm, p/n: pft10900 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed: f current and manufactured.Dimensional inspection: n/a.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: SHAVER H 9MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; GM
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 15487067
• MDR Text Key: 300627966
• Report Number: 3013730328-2022-00076
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04260397082690
• UDI-Public: 04260397082690
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFT10900
• Device Catalogue Number: PFT10900
• Device Lot Number: E17DI03981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 82 YR
• Patient Sex: Female