MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO STRAIGHT PLATE 4 HOLES; PLATE, BONE

Catalog Number 421.504

Device Problem Crack (1135)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in china as follows: it was reported that during the surgery, opened the packing, noted the device was cracked.Another device was used to complete the surgery.There was no surgical delay.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) cranial-pl 1.6 straight w/cent-space 4ho this is report 1 of 1 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.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.E1:first affiliated hospital of zhejiang university school of medicine e3: reporter is a j&j sales representative.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.

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 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.

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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo showed the plate in a ziplock bag and not the original packaging.A mark is visible on the top surface of the plate around one of the holes.The mark is only visible on the top surface of the plate and it cannot be determined what the mark is from the photo.The plate was returned and a visual analysis of the plate found a gouge in the top surface of the plate around one of the holes in the same location noted in the photo provided with the complaint.The gouge is consistent with impact of another metallic device and there is also a burr raised on the edge of the plate.The original product packaging is not available and therefore it cannot be examined to see if there is corresponding damage that may indicate the damage was potentially caused post-manufacturing.A review of the manufacturing process confirmed that a 100% visual inspection is performed and there were no processes identified that could have caused the gouge observed.The complaint condition is not confirmed for the presence of a crack but the complaint is being noted as confirmed due to the presence of the gouge on the top surface of the plate.A dimensional inspection and document/specification review were not completed as the it would not be relevant to the reported issue of a crack.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for cranial-pl 1.6 straight w/cent-space 4ho.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.Device history review (dhr): part number: 421.504, lot number: 4343p54, part manufacturing date: 06 february 2023, manufacturing site: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint-related anomalies.The device history record shows lot 4343p54 of ti low profile neuro straight plates was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lot 1343p26 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 98p1130 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint-related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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: TI LOW PROFILE NEURO STRAIGHT PLATE 4 HOLES
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14846
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18229359
• MDR Text Key: 329266000
• Report Number: 8030965-2023-14968
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819753570
• UDI-Public: (01)07611819753570
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 421.504
• Device Lot Number: 4343P54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1