MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SPREADER- ANGLED; FORCEPS

Model Number PDL114

Device Problems Use of Device Problem (1670); Compatibility Problem (2960); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, the distributor for the surgeon listed received an instrument set and the 4mm rongeur was broken at the handle because it was missing the lever piece that allows the handles to articulate.This did not allow the instrument to function as intended, so it was not used during the case.Other instruments were used to successfully complete the case.No patient injury or harm was indicated.The spreader in their possession was later identified to be broken as well because it would not ratchet as intended due to spring damage in the handle component.This report is for one (1) vertebral body spreader- angled.This is report 1 of 2 for complaint (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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a distributor.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.H4: device was manufactured in week 11 of 2005.Part number: pdl114, lot number: a7oa11, manufacturing site: tuttlingen, release to warehouse date: week 11, 2005.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that vertebral body spreader- angled had no visible defect identifiable.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for vertebral body spreader- angled.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this 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.H3, h4, h6: 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 the vertebral body spreader- angled had the serrated teeth of the ratchet overall worn.No signs of breakage were observed, however, the wear condition observed could have contributed to the functional issues reported of the device not ratcheting as intended.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection for the vertebral body spreader- angled was not performed as it is not applicable to the complaint condition.A functional test was performed, the forceps were loose and the ratchet did not lock tightly as intended.The overall complaint was confirmed as the observed condition of the vertebral body spreader- angled would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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: pdl114, lot number: a7oa11 manufacturing site: tuttlingen , release to warehouse date: 22-mar-2005.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 18 years old).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: VERTEBRAL BODY SPREADER- ANGLED
• Type of Device: 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16985993
• MDR Text Key: 316211227
• Report Number: 8030965-2023-06495
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10705034700212
• UDI-Public: (01)10705034700212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• 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
• Device Operator: Health Professional
• Device Model Number: PDL114
• Device Catalogue Number: PDL114
• Device Lot Number: A7OA11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 07/04/2023; 08/22/2023
• Supplement Dates FDA Received: 07/07/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2005
• 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
• Treatment: 40 DEG UP-BIT LAMNECT PNCH 4MM W/330MM L