MAUDE Adverse Event Report: SYNTHES GMBH BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET; FORCEPS

Catalog Number	399.097
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a posterior decompression surgery performed was performed on (b)(6) 2024.In the surgery, ratchet engagement of the bone-spread in question was extremely poor and operability was problematic.Surgery was completed successfully.This report is for one bone spreader with 8mm blade medium handle-soft ratchet 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.E1: initial reporter is j&j company representative h3, h6: 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.
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.Additional narrative: 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.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found no problems or damage in the device.Only signs and wear of normal use.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed.The locking mechanism was open and close several times it was noted that the snap in-lever fell lose for the internal components therefore the device does not work as expected.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the bone-spread softlo w/8 l220 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 reported 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 history review (dhr): part number: 399.097; lot number: 9188p34 (wo# (b)(4)).Manufacturing site: tuttlingen.Release to warehouse date: 18-jan-2024.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19762971
• Report Number: 8030965-2024-08834
• Device Sequence Number: 8478815
• Product Code: HTD
• UDI-Device Identifier: 07611819220997
• UDI-Public: (01)07611819220997(11)240118(10)9188P34
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: 399.097
• Device Lot Number: 9188P34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/14/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/14/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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