MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM; BONE PLATE

Catalog Number 04.503.638.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Increased Appetite (4570)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on jul.29, 2021, the patient underwent for a revision surgery due to infection.On (b)(6) 2021 the primary fibular reconstruction procedure in the mandible was performed to treat ameloblastoma.Trumatch was applied without surgical delay.It was unknown if the revision surgery completed successfully.The patient outcome unknown.No further information is available.This complaint involves twelve (12) devices.This report is for (1) 2.4mm ti matrixmandible locking screw slf-tpng 8mm.This report is 7 of 12 for (b)(4).Related product 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.H4, h6: product code: 04.503.638.01s, lot number: 80p1388, manufacturing site: bettlach, release to warehouse date: 07 december 2020, expiry date: 01 november 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12387861
• MDR Text Key: 268996469
• Report Number: 8030965-2021-07352
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939851
• UDI-Public: (01)07611819939851
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.638.01S
• Device Lot Number: 80P1388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CMD PATIENT SPECIFIC PLATE F/MANDIB MATM; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L14 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L18 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP
• Patient Outcome(s): Required Intervention
• Patient Sex: Female