MAUDE Adverse Event Report: SYNTHES GMBH ALUMINUM BLUNT PELVIC RETRACTOR

Catalog Number	03.100.107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from australia reports an event as follows: it was reported that on (b)(6) 2023 during incoming loan kit inspection, the tip of the instrument in question was found with a hole in it.There was no reported patient or procedure interaction.No further information is available.This report is for an aluminum blunt pelvic retractor.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h6: 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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part# 03.100.107.Synthes lot # h497025.Supplier lot# h497025.Release to warehouse date: 19 april 2018.Supplier: (b)(4).No ncrs were generated during production.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 03.100.107, radiolucent pelvic retractor blunt l274 had a hole at the tip.No further evidence can be observed from the photo to determine the root cause.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device 03.100.107, radiolucent pelvic retractor blunt l274 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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.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 device does not found signs of breakage at the radiolucent pelvic retractor blunt l274.However the device has a hole at the tip.This type of damage was caused most likely due to an unintended interaction with a drilling device.According to surgical technique "pelvic implants and instruments for internal fixation of fractures and/or dislocations of the pelvis" this device should not be drilled.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the radiolucent pelvic retractor blunt l274 would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: ALUMINUM BLUNT PELVIC RETRACTOR
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18141077
• Report Number: 8030965-2023-14376
• Device Sequence Number: 20828817
• Product Code: GAD
• UDI-Device Identifier: 10886982071057
• UDI-Public: (01)10886982071057
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 03.100.107
• Device Lot Number: H497025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown