MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK; BONE PLATE

Catalog Number 04.503.740S

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 history lot: part: 04.503.740s, lot: 6l77621, manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: march 16, 2020, expiry date: march 1, 2030.Device was first manufactured unsterile under the lot 42p7768 in the us and sterilized afterwards.As this complaint is neither packaging nor sterilization related and as the traceability of the lots is fully ensured in the erp system only the manufacturing documents of the unsterile device 04.503.740 with lot 42p7768 were reviewed: part number: 04.503.740, lot number: 42p7768, part manufacturing date: feb 17, 2020, manufacturing site: (b)(4).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 42p7768 of ti matrixmandible 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 10l8420 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 h852479 met all specifications with no issues documented that would contribute to this complaint condition.Device history review: 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery for lower jaw with the matrixmandible plate in question.Prior to the procedure, on (b)(6) 2020, the surgeon requested the plate and the sales rep arranged it.At an unknown later date, the surgeon requested another different plate (matrix mandible double angle recon plate, p/n: unk) because the incision might be larger, but the sales rep did not arrange the double angle plate by mistake.On (b)(6) 2020 the surgeon tried to use the double angle plate, but he found that it was not arranged.The surgeon instead used the matrixmandible plate devising the incision.During the surgery, the matrixmandible plate broke during bending.The surgeon used another matrixmandible plate and the surgery was completed successfully with less than thirty (30) minutes delay.No further information is available.This report is for one (1) ti matrixmandible 7x23 angle recon pl right 2.5mm thick.This is report 1 of 1 for (b)(4).

Event Description

Updated event description: it was reported that on (b)(6) 2020, the patient underwent the surgery for lower jaw with the plate (matrix mandible recon plate, p/n: 04.503.740s) in question.On (b)(6) the surgeon requested the plate (matrix mandible recon plate, p/n: 04.503.740s), and the sales rep arranged it.At a later date, the surgeon requested another plate (matrix mandible double angle recon plate, p/n: unk) because the incision might be larger, but the sales rep didn¿t arrange the double angle plate by mistake.On (b)(6) the surgeon tried to use the double angle plate, but he found that the double angle plate was not arranged.The surgeon had no choice but to use the plate (matrix mandible recon plate, p/n: 04.503.740s) devising the incision.During the surgery, the plate broke because the double angle plate was appropriate originally and the surgeon used the plate forcibly.The surgeon used another plate (matrix mandible recon plate, p/n: 04.503.740s) and the surgery was completed successfully with less than 30 minutes delay.After the surgery on (b)(6) the sales rep found that the lot number imprinted at the broken plate is different from the lot number of the plate package.No further information is available.This complaint involves two (2) devices.

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, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 history lot part: 04.503.740s, lot: 6l77621, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: mar.16, 2020, expiry date: mar.01, 2030.Device was first manufactured unsterile under the lot 42p7768 in the us and sterilized afterwards.As this complaint is neither packaging nor sterilization related and as the traceability of the lots is fully ensured in the erp system only the manufacturing documents of the unsterile device 04.503.740 with lot 42p7768 were reviewed: part number: 04.503.740, lot number: 42p7768, part manufacturing date: february 17, 2020, 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 42p7768 of ti matrixmandible plates was processed through the normal manufacturing and inspection operations with no rework or non conformances 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 10l8420 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 h852479 met all specifications with no issues documented that would contribute to this complaint condition.Device history review 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.

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.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

This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10563492
• MDR Text Key: 215886905
• Report Number: 8030965-2020-07277
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819973916
• UDI-Public: (01)07611819973916
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.740S
• Device Lot Number: 6L77621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: MATRIXMANDIBLE
• Patient Outcome(s): Required Intervention