MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/LEFT/86MM; PLATE, FIXATION, BONE

Model Number 02.112.139

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

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

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.Date of event: only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Additional device product codes: hwc.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2022, the surgeon performed a removal of hardware due to pain and irritation.The procedure was successfully completed.No further information is available.This report involves one 2.7mm/3.5mm lcp lateral distal fibula plate 4h/left/86mm.This is report 1 of 14 for (b)(4).

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/LEFT/86MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15628356
• MDR Text Key: 301977961
• Report Number: 8030965-2022-08368
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982033918
• UDI-Public: 10886982033918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083213
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.112.139
• Device Catalogue Number: 02.112.139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 12; 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 14; 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 14; 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 16; 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 18; 2.7MM CORTEX SCREW SELF-TAPPING 28MM; 2.7MM CORTEX SCREW SELF-TAPPING 34MM; 2.7MM CORTEX SCREW SELF-TAPPING 45MM; 2.7MM CORTEX SCREW SELF-TAPPING 55MM; 3.5MM CORTEX SCREW SELF-TAPPING 14MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM CORTEX SCREW SELF-TAPPING 18MM; LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female