MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.535 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.535

Device Problem Defective Device (2588)

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

Event Date 11/28/2023

Event Type  malfunction  

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 not expected to be returned for manufacturer review/investigation.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.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 Description

It was reported that during a procedure on (b)(6), 2023, it was discovered that the peek psi implant had been manufactured with multiple suture holes when the surgeon had requested that it be manufactured with only two.The implant was used, regardless.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a psi sd800.535 peek implant.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.H11 additional narrative: h3, h4, h6 analysis summary: the depuy synthes team conducted a visual inspection of the returned photo.The visual analysis of the photo found that it showed the patient specific implant in a plastic bag with the sterilization strip visible.The markings on the implant were covered by the sterilization strip such that only the part number was visible.Numerous holes in the implant are visible and it was confirmed that these are the standard grid of 2 mm drainage holes.It was also confirmed that the drainage holes were in the design presented to and approved by the surgeon.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection could not be completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, it has been determined that the holes noted by the surgeon were the drainage holes and not additional suture holes and that the design including the drainage holes was approved prior to production.Therefore the complaint is unconfirmed and 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.Device history review (dhr): part number: sd800.535-us lot number: 8619p17 part manufacture date: 11/14/2023 manufacturing location: brandywine part expiration date: n/a nonconformance noted: n/a a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows the peek psi implant was processed through operations of the released routing and had met all specification criteria at the time of release with no issues documented that would contribute to the complaint condition.The product lot met all specification criteria at the time of release with no issues documented that would contribute to the complaint condition.Corrected data: g1: manufacture site updated 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: PSI SD800.535 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1301 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18375631
• MDR Text Key: 331378802
• Report Number: 8030965-2023-15947
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065946
• UDI-Public: (01)10887587065946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.535
• Device Lot Number: TCMF-2200569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1